Trial Outcomes & Findings for Sleep Duration and Blood Pressure During Sleep (NCT NCT05062161)
NCT ID: NCT05062161
Last Updated: 2026-06-08
Results Overview
Mean of valid BP readings during the sleep period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean sleep systolic BP (mmHg) at baseline and 8 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Baseline, 8 weeks
Results posted on
2026-06-08
Participant Flow
66 participants enrolled in the study. 1 participant withdrew prior to randomization.
Participant milestones
| Measure |
Sleep Hygiene/Extension Intervention
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Control Condition
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Duration and Blood Pressure During Sleep
Baseline characteristics by cohort
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 16.6 • n=9 Participants
|
36.7 years
STANDARD_DEVIATION 15.1 • n=27 Participants
|
37.3 years
STANDARD_DEVIATION 15.8 • n=267 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
38 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=9 Participants
|
32 participants
n=27 Participants
|
65 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksMean of valid BP readings during the sleep period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean sleep systolic BP (mmHg) at baseline and 8 weeks.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks
Baseline
|
100.8 mmHg
Standard Deviation 13.3
|
100.0 mmHg
Standard Deviation 9.1
|
|
Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks
8 Weeks
|
101.4 mmHg
Standard Deviation 13.2
|
102.3 mmHg
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksMean of valid BP readings during the sleep period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean sleep diastolic BP (mmHg) at baseline and 8 weeks.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
Baseline
|
58.6 mmHg
Standard Deviation 8.2
|
57.9 mmHg
Standard Deviation 6.5
|
|
Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
8 weeks
|
60.0 mmHg
Standard Deviation 7.8
|
60.1 mmHg
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksMean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake systolic BP (mmHg) at baseline and 8 weeks.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 Weeks
Baseline
|
117.8 mmHg
Standard Deviation 11.6
|
119.7 mmHg
Standard Deviation 8.8
|
|
Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 Weeks
8 weeks
|
115.9 mmHg
Standard Deviation 13.1
|
119.2 mmHg
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksMean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake diastolic BP (mmHg) at baseline and 8 weeks.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
Baseline
|
73.5 mmHg
Standard Deviation 8.0
|
75.7 mmHg
Standard Deviation 6.8
|
|
Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
8 weeks
|
72.7 mmHg
Standard Deviation 7.6
|
74.6 mmHg
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksMean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake 24-hour systolic BP (mmHg) at baseline and 8 weeks.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 Weeks
Baseline
|
113.2 mmHg
Standard Deviation 12.3
|
114.4 mmHg
Standard Deviation 8.5
|
|
Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 Weeks
8 weeks
|
111.6 mmHg
Standard Deviation 12.6
|
114.1 mmHg
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksMean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake 24-hour diastolic BP (mmHg) at baseline and 8 weeks.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
Baseline
|
69.4 mmHg
Standard Deviation 7.9
|
70.9 mmHg
Standard Deviation 6.3
|
|
Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
8 weeks
|
68.9 mmHg
Standard Deviation 6.9
|
70.4 mmHg
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks24-hour high frequency heart rate variability will be estimated from R-R interval data from the Cardio SOLO device at baseline and 8 weeks and compared across randomization arms.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
24-hour High Frequency Heart Rate Variability
Baseline
|
680.3 ms^2
Standard Deviation 749.3
|
510.6 ms^2
Standard Deviation 360.0
|
|
24-hour High Frequency Heart Rate Variability
8 weeks
|
737.6 ms^2
Standard Deviation 839.8
|
574.9 ms^2
Standard Deviation 550.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeksThis is to measure if the intervention (sleep hygiene/extension) would increase mean sleep duration for participants randomized to sleep hygiene/extension, actigraphy-derived sleep duration will be used to evaluate the intervention. Actigraphy-derived mean sleep duration will be calculated daily as the total time between the sleep and awake period as defined on the Fitbit device in number of hours.
Outcome measures
| Measure |
Control Condition
n=33 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
Sleep Hygiene/Extension Intervention
n=32 Participants
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
|
|---|---|---|
|
Actigraphy-derived Mean Sleep Duration
Baseline
|
7.16 hours
Standard Deviation 2.14
|
7.28 hours
Standard Deviation 1.58
|
|
Actigraphy-derived Mean Sleep Duration
8 weeks
|
7.26 hours
Standard Deviation 2.02
|
6.72 hours
Standard Deviation 1.84
|
Adverse Events
Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Hygiene/Extension Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marwah Abdalla
Columbia University Irving Medical Center
Phone: 212 342 1275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place