Trial Outcomes & Findings for Sleep and Circadian Mechanisms of Non-dipping Blood Pressure (NCT NCT03558893)
NCT ID: NCT03558893
Last Updated: 2026-07-20
Results Overview
Systolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline Night Average
Results posted on
2026-07-20
Participant Flow
Participants were recruited from the general population using established methods via flyers across the OHSU campus, community bulletin boards, internet advertisements (ResearchMatch.com, OCTRI's research Data Warehouse, clinicaltrials.gov, Craigslist, Facebook-using lab or The Oregon Institute of Occupational Health Sciences accounts), and booths at community health fairs (see protocol for additional details).
Nothing to report
Participant milestones
| Measure |
White Adults
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
5
|
|
Overall Study
COMPLETED
|
19
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
White Adults
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
0
|
Baseline Characteristics
Participants who did not complete the in lab study portion were excluded from all statistical analyses.
Baseline characteristics by cohort
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 10.0 • n=20 Participants
|
45.2 Years
STANDARD_DEVIATION 9.2 • n=20 Participants
|
43.3 Years
STANDARD_DEVIATION 9.7 • n=40 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
2 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
13 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
3 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
11 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
5 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
5 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
19 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
1 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
5 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
23 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=20 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
0 Participants
n=40 Participants • Participants who did not complete the in lab study portion were excluded from all statistical analyses.
|
PRIMARY outcome
Timeframe: Baseline Night AveragePopulation: All participants who completed the in-laboratory study are included.
Systolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg.
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Nighttime Systolic Blood Pressure
|
101.6 mmHg
Standard Error 2.1
|
92.4 mmHg
Standard Error 4.0
|
PRIMARY outcome
Timeframe: Baseline Night AveragePopulation: All participants who completed the in-laboratory study are included.
Diastolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg.
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Nighttime Diastolic Blood Pressure
|
60.5 mmHg
Standard Error 1.4
|
59.0 mmHg
Standard Error 1.4
|
PRIMARY outcome
Timeframe: Baseline Daytime AveragePopulation: All participants who completed the in-laboratory study are included.
Systolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg.
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Daytime Systolic Blood Pressure
|
116.6 mmHg
Standard Error 8.6
|
120.5 mmHg
Standard Error 9.7
|
PRIMARY outcome
Timeframe: Baseline Daytime AveragePopulation: All participants who completed the in-laboratory study are included.
Diastolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg.
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Daytime Diastolic Blood Pressure
|
68.1 mmHg
Standard Error 6.5
|
72.6 mmHg
Standard Error 7.2
|
PRIMARY outcome
Timeframe: 7 days in the laboratoryPopulation: All participants who completed the in-laboratory study are included.
Change in systolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out).
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Change in Systolic Blood Pressure Across Sleep Period
|
-0.36 mmHg/hour
Standard Error 0.5
|
-0.6 mmHg/hour
Standard Error 0.5
|
PRIMARY outcome
Timeframe: 7 days in the laboratoryPopulation: All participants who completed the in-laboratory study are included.
Change in diastolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out).
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Change in Diastolic Blood Pressure Across Sleep Period
|
-0.06 mmHg/hour
Standard Error 0.14
|
0.4 mmHg/hour
Standard Error 0.14
|
PRIMARY outcome
Timeframe: 7 days in the laboratoryPopulation: All participants who completed the in-laboratory study are included.
Systolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of systolic blood pressure while controlling for (averaging out) any ongoing behaviors.
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Circadian Amplitude of Systolic Blood Pressure When Awake
|
2.2 mmHg
Standard Error 0.4
|
1.4 mmHg
Standard Error 0.8
|
PRIMARY outcome
Timeframe: 7 days in the laboratoryPopulation: All participants who completed the in-laboratory study are included.
Diastolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of diastolic blood pressure while controlling for (averaging out) any ongoing behaviors.
Outcome measures
| Measure |
White Adults
n=19 Participants
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 Participants
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
Circadian Amplitude of Diastolic Blood Pressure When Awake
|
0.8 mmHg
Standard Error 0.2
|
1.2 mmHg
Standard Error 0.6
|
Adverse Events
White Adults
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Black Adults
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
White Adults
n=25 participants at risk
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
Black Adults
n=5 participants at risk
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
|
|---|---|---|
|
General disorders
IV Site Discomfort
|
4.0%
1/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
0.00%
0/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Participant withdraw from study
|
24.0%
6/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
0.00%
0/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Issues post discharge
|
0.00%
0/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
40.0%
2/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Grip Test Discomfort
|
0.00%
0/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
40.0%
2/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Bike Test Discomfort
|
4.0%
1/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
0.00%
0/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Stress Test Discomfort
|
4.0%
1/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
0.00%
0/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
General Discomfort
|
4.0%
1/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
20.0%
1/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Blood Draw Discomfort
|
4.0%
1/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
0.00%
0/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Study Meals
|
0.00%
0/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
20.0%
1/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Holter Discomfort
|
0.00%
0/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
20.0%
1/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Blood Draw Discontinued
|
0.00%
0/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
20.0%
1/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Constipation
|
4.0%
1/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
0.00%
0/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Lead Discomfort
|
20.0%
5/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
20.0%
1/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
|
General disorders
Tilt Table Discomfort
|
0.00%
0/25 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
20.0%
1/5 • From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
|
Additional Information
Nicole P. Bowles
Oregon Institute of Occupational Health Sciences, OHSU
Phone: 503-494-4273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place