Trial Outcomes & Findings for Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses (NCT NCT05419830)
NCT ID: NCT05419830
Last Updated: 2024-12-17
Results Overview
The mean sleep time systolic blood pressure dip will be quantified by calculating the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value for each participant across the 48-hour recording period comparing baseline and post-intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline and at 6 weeks
Results posted on
2024-12-17
Participant Flow
Recruitment started June 2022 through September 2023. The initial screening was completed telephonically and once screened eligible, the interested participants underwent study related assessments and procedures at the study research suite - Continence Research Unit at University of Pittsburgh Medical Center, Montefiore Hospital located in Pittsburgh, Pennsylvania
After the telephone screening, eligible participants were scheduled for the first in-person study visit. No study procedures were performed till informed consent was obtained.
Participant milestones
| Measure |
AM (Morning) Antihypertensive Dosing- Control Arm
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
AM antihypertensive dosing: participants will be asked to continue taking their antihypertensive medication within an hour of awakening
|
BBTI Arm
participants will receive the brief behavioral treatment for insomnia (BBTI) by the study nurse. Participants will also be asked to take their antihypertensive medication within an hour of awakening
BBTI: Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
PM (Evening) Antihypertensive Dosing or Chronotherapy Arm
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
PM antihypertensive dosing or Chronotherapy: participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses
Baseline characteristics by cohort
| Measure |
AM Antihypertensive Dosing Arm
n=10 Participants
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
AM antihypertensive dosing: participants will be asked to continue taking their antihypertensive medication within an hour of awakening
|
BBTI Arm
n=10 Participants
participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening
BBTI: Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
PM Antihypertensive Dosing or Chronotherapy Arm
n=10 Participants
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
PM antihypertensive dosing or Chronotherapy: participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Continuous
|
73.9 years
STANDARD_DEVIATION 5 • n=99 Participants
|
69.4 years
STANDARD_DEVIATION 4.6 • n=107 Participants
|
71.5 years
STANDARD_DEVIATION 4.2 • n=206 Participants
|
71.6 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
Office systolic blood pressure
|
144.9 mm Hg
STANDARD_DEVIATION 13.3 • n=99 Participants
|
137.4 mm Hg
STANDARD_DEVIATION 9.5 • n=107 Participants
|
155.5 mm Hg
STANDARD_DEVIATION 14.6 • n=206 Participants
|
145.8 mm Hg
STANDARD_DEVIATION 12.5 • n=7 Participants
|
|
Office diastolic blood pressure
|
80.4 mm Hg
STANDARD_DEVIATION 8.3 • n=99 Participants
|
79.9 mm Hg
STANDARD_DEVIATION 11 • n=107 Participants
|
85.7 mm Hg
STANDARD_DEVIATION 11.7 • n=206 Participants
|
82 mm Hg
STANDARD_DEVIATION 10.5 • n=7 Participants
|
|
Office heart rate
|
66.5 beats per minute
STANDARD_DEVIATION 13.4 • n=99 Participants
|
63.6 beats per minute
STANDARD_DEVIATION 8.7 • n=107 Participants
|
68.5 beats per minute
STANDARD_DEVIATION 8.9 • n=206 Participants
|
66.2 beats per minute
STANDARD_DEVIATION 10.4 • n=7 Participants
|
|
Body mass index (BMI)
|
31.2 kg/m2
STANDARD_DEVIATION 2.8 • n=99 Participants
|
34 kg/m2
STANDARD_DEVIATION 8.7 • n=107 Participants
|
31.4 kg/m2
STANDARD_DEVIATION 6.5 • n=206 Participants
|
32.2 kg/m2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
|
Post void residual
|
47 ml
STANDARD_DEVIATION 75.3 • n=99 Participants
|
15.7 ml
STANDARD_DEVIATION 11.4 • n=107 Participants
|
18.7 ml
STANDARD_DEVIATION 35 • n=206 Participants
|
35.4 ml
STANDARD_DEVIATION 63.1 • n=7 Participants
|
|
Calcium channel blocker
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Beta-blocker
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Angiotensin converting enzyme inhibitor/ Angiotensin receptor blocker
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Thiazide diuretic
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Loop diuretic
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Alpha- blocker
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Statin
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Antidepressant
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Nonsteroidal anti-inflammatory drugs (NSAIDs)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Antimuscarinic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
oral hypoglycemic
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Insulin
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Hypnotic
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 6 weeksThe mean sleep time systolic blood pressure dip will be quantified by calculating the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value for each participant across the 48-hour recording period comparing baseline and post-intervention
Outcome measures
| Measure |
AM Antihypertensive Dosing Arm
n=10 Participants
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
AM antihypertensive dosing: participants will be asked to continue taking their antihypertensive medication within an hour of awakening
|
BBTI Arm
n=10 Participants
participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening
BBTI: Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
PM Antihypertensive Dosing or Chronotherapy Arm
n=10 Participants
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
PM antihypertensive dosing or Chronotherapy: participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
|
|---|---|---|---|
|
Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention
|
-0.4 percentage of daytime mean SBP
Standard Deviation 7.9
|
7.3 percentage of daytime mean SBP
Standard Deviation 13.5
|
3.9 percentage of daytime mean SBP
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline and at 6 weekschange in nocturia frequency pre- vs post-intervention as determined by 3-day bladder diary completed at both time points
Outcome measures
| Measure |
AM Antihypertensive Dosing Arm
n=10 Participants
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
AM antihypertensive dosing: participants will be asked to continue taking their antihypertensive medication within an hour of awakening
|
BBTI Arm
n=10 Participants
participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening
BBTI: Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
PM Antihypertensive Dosing or Chronotherapy Arm
n=10 Participants
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
PM antihypertensive dosing or Chronotherapy: participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
|
|---|---|---|---|
|
Change in Nocturia Frequency Pre- vs Post-intervention
|
-0.3 number of episodes
Standard Deviation 1.0
|
-0.6 number of episodes
Standard Deviation 0.7
|
-0.3 number of episodes
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and at 6 weeksNPi is calculated using nighttime and daytime urine volumes as reported in 3-day bladder diary as follows: NPi=(nocturnal urine volume/24-hour volume)\*100
Outcome measures
| Measure |
AM Antihypertensive Dosing Arm
n=10 Participants
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
AM antihypertensive dosing: participants will be asked to continue taking their antihypertensive medication within an hour of awakening
|
BBTI Arm
n=10 Participants
participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening
BBTI: Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
PM Antihypertensive Dosing or Chronotherapy Arm
n=10 Participants
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
PM antihypertensive dosing or Chronotherapy: participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
|
|---|---|---|---|
|
Change in Nocturnal Polyuira Index (NPi) Pre vs Post-intervention
|
0.5 % of 24h urine output excreted at night
Standard Deviation 7.4
|
-6.0 % of 24h urine output excreted at night
Standard Deviation 9.7
|
-0.9 % of 24h urine output excreted at night
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline and at 6 weeksPSQI is a self-rated questionnaire for evaluating subjective sleep quality. PSQI global scores range from 0-21, with higher scores indicating worse sleep quality and negative change indicates sleep improvement.
Outcome measures
| Measure |
AM Antihypertensive Dosing Arm
n=10 Participants
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
AM antihypertensive dosing: participants will be asked to continue taking their antihypertensive medication within an hour of awakening
|
BBTI Arm
n=10 Participants
participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening
BBTI: Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
PM Antihypertensive Dosing or Chronotherapy Arm
n=10 Participants
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
PM antihypertensive dosing or Chronotherapy: participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
|
|---|---|---|---|
|
Change in Global Pittsburgh Sleep Quality Index (PSQI) Score Pre- vs Post-intervention
|
0.5 score on a scale
Standard Deviation 2.9
|
-1.4 score on a scale
Standard Deviation 2.2
|
-1.2 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and at 6 weeksSleep efficiency will be calculated as (total sleep time/time in bed)\*100 with time in bed and total sleep times obtained from Zmachine worn by participants pre- and post-intervention
Outcome measures
| Measure |
AM Antihypertensive Dosing Arm
n=10 Participants
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
AM antihypertensive dosing: participants will be asked to continue taking their antihypertensive medication within an hour of awakening
|
BBTI Arm
n=10 Participants
participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening
BBTI: Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
PM Antihypertensive Dosing or Chronotherapy Arm
n=10 Participants
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
PM antihypertensive dosing or Chronotherapy: participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
|
|---|---|---|---|
|
Change in Sleep Efficiency Pre- vs Post-intervention
|
-7 %: (total sleep time/time in bed)*100
Standard Deviation 15.3
|
12 %: (total sleep time/time in bed)*100
Standard Deviation 7.8
|
-3 %: (total sleep time/time in bed)*100
Standard Deviation 11.8
|
Adverse Events
AM Antihypertensive Dosing Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BBTI Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PM Antihypertensive Dosing or Chronotherapy Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place