Trial Outcomes & Findings for Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production (NCT NCT03883724)
NCT ID: NCT03883724
Last Updated: 2022-12-22
Results Overview
Nocturnal Polyuria Index (NPI) is the percentage of 24-hour urine production excreted at night. It is measured using 3-day bladder diary that participants will complete pre- and post-intervention in which the participants document the time and volume of each void during the day and night for 3 days. NPI is calculated using a) nocturnal urine volume (determined by adding the volume of all voids between the times marked in the bladder diary as going to bed with the intent of sleeping and the first awakening to void. The first void after waking is included in the nighttime urine volume), and b) 24-hour urine volume. NPI is calculated as: nocturnal urine volume /24-hour urine volume
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
change from baseline nocturnal polyuria index at 4 weeks
Results posted on
2022-12-22
Participant Flow
Recruitment started Jan 2019 through April 2021. 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 UPMC Montefore Hospital located in Pittsburgh, PA
After the telephone screening, the eligible participants completed a home sleep apnea assessment using device ApneaLink Air that was sent to them via mail with instructions for use at home. Those with AHI≥15 were excluded per study exclusion criteria before the in-person Visit 1 or signing the informed consent.
Participant milestones
| Measure |
Brief Behavioral Treatment for Insomnia
This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia
Brief behavioral treatment of insomnia (BBTI): The BBTI consists of a 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. The brief behavioral treatment component will focus on four behaviors that promote sleep through homeostatic, circadian, or association mechanisms. 50 These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
Information-only Control
This group is called information-only control. They will be provided sleep-related information. They will also view a video content of which overlap substantially with BBTI but without individualized behavioral instructions.
Information-only control (IC): The IC condition is intended to emulate the behavioral treatment information generally to available patients. It includes instructions to review hand out on healthy sleep practices. We will also use patient education videos on insomnia developed locally and widely used in clinical research. The content of these videos overlap substantially with BBTI but without individualized behavioral instructions. Two weeks later, IC participants will receive a 10-minute follow-up telephone call to encourage continued participation. Participants will be referred to the brochures for specific sleep-related questions.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
27
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
Baseline characteristics by cohort
| Measure |
Brief Behavioral Treatment for Insomnia
n=29 Participants
This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia
Brief behavioral treatment of insomnia (BBTI): The BBTI consists of a 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. The brief behavioral treatment component will focus on four behaviors that promote sleep through homeostatic, circadian, or association mechanisms. 50 These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
Information-only Control
n=27 Participants
This group is called information-only control. They will be provided sleep-related information. They will also view a video content of which overlap substantially with BBTI but without individualized behavioral instructions.
Information-only control (IC): The IC condition is intended to emulate the behavioral treatment information generally to available patients. It includes instructions to review hand out on healthy sleep practices. We will also use patient education videos on insomnia developed locally and widely used in clinical research. The content of these videos overlap substantially with BBTI but without individualized behavioral instructions. Two weeks later, IC participants will receive a 10-minute follow-up telephone call to encourage continued participation. Participants will be referred to the brochures for specific sleep-related questions.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
27.2 kg/m2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
28.4 kg/m2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
27.8 kg/m2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Post void residual
|
11.6 ml
STANDARD_DEVIATION 18.5 • n=5 Participants
|
19.3 ml
STANDARD_DEVIATION 28.8 • n=7 Participants
|
15.2 ml
STANDARD_DEVIATION 24 • n=5 Participants
|
|
Creatinine
|
0.86 mg/dL
STANDARD_DEVIATION 0.21 • n=5 Participants
|
0.94 mg/dL
STANDARD_DEVIATION 0.23 • n=7 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Calcium channel blocker
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Beta-blocker
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
ACE-I/ARB
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Thiazide diuretic
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Loop diuretic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Anti-depressant
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
NSAIDS
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Proton pump inhibitor/ H2 blocker
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Antimuscarinic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Alpha-blocker
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change from baseline nocturnal polyuria index at 4 weeksNocturnal Polyuria Index (NPI) is the percentage of 24-hour urine production excreted at night. It is measured using 3-day bladder diary that participants will complete pre- and post-intervention in which the participants document the time and volume of each void during the day and night for 3 days. NPI is calculated using a) nocturnal urine volume (determined by adding the volume of all voids between the times marked in the bladder diary as going to bed with the intent of sleeping and the first awakening to void. The first void after waking is included in the nighttime urine volume), and b) 24-hour urine volume. NPI is calculated as: nocturnal urine volume /24-hour urine volume
Outcome measures
| Measure |
Brief Behavioral Treatment for Insomnia
n=29 Participants
This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia
Brief behavioral treatment of insomnia (BBTI): The BBTI consists of a 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. The brief behavioral treatment component will focus on four behaviors that promote sleep through homeostatic, circadian, or association mechanisms. 50 These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
Information-only Control
n=27 Participants
This group is called information-only control. They will be provided sleep-related information. They will also view a video content of which overlap substantially with BBTI but without individualized behavioral instructions.
Information-only control (IC): The IC condition is intended to emulate the behavioral treatment information generally to available patients. It includes instructions to review hand out on healthy sleep practices. We will also use patient education videos on insomnia developed locally and widely used in clinical research. The content of these videos overlap substantially with BBTI but without individualized behavioral instructions. Two weeks later, IC participants will receive a 10-minute follow-up telephone call to encourage continued participation. Participants will be referred to the brochures for specific sleep-related questions.
|
|---|---|---|
|
Change in Nocturnal Polyuria Index
Post-intervention
|
34.5 percentage of urine volume
Standard Deviation 13
|
37.8 percentage of urine volume
Standard Deviation 8.6
|
|
Change in Nocturnal Polyuria Index
Pre-intervention
|
41.7 percentage of urine volume
Standard Deviation 9.9
|
41.7 percentage of urine volume
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: change from baseline nocturia episodes each night at 4 weeksNocturia=number of awakenings to void each night
Outcome measures
| Measure |
Brief Behavioral Treatment for Insomnia
n=29 Participants
This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia
Brief behavioral treatment of insomnia (BBTI): The BBTI consists of a 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. The brief behavioral treatment component will focus on four behaviors that promote sleep through homeostatic, circadian, or association mechanisms. 50 These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
Information-only Control
n=27 Participants
This group is called information-only control. They will be provided sleep-related information. They will also view a video content of which overlap substantially with BBTI but without individualized behavioral instructions.
Information-only control (IC): The IC condition is intended to emulate the behavioral treatment information generally to available patients. It includes instructions to review hand out on healthy sleep practices. We will also use patient education videos on insomnia developed locally and widely used in clinical research. The content of these videos overlap substantially with BBTI but without individualized behavioral instructions. Two weeks later, IC participants will receive a 10-minute follow-up telephone call to encourage continued participation. Participants will be referred to the brochures for specific sleep-related questions.
|
|---|---|---|
|
Change in Nocturia
Pre-intervention
|
2.3 awakenings, as reported on bladder diary
Standard Deviation .6
|
2.1 awakenings, as reported on bladder diary
Standard Deviation .7
|
|
Change in Nocturia
Post-intervention
|
1.3 awakenings, as reported on bladder diary
Standard Deviation .6
|
1.8 awakenings, as reported on bladder diary
Standard Deviation .6
|
SECONDARY outcome
Timeframe: Change from baseline duration of uninterrupted sleep at 4 weeksDuration of uninterrupted sleep is the first uninterrupted sleep period before first awakening to void
Outcome measures
| Measure |
Brief Behavioral Treatment for Insomnia
n=29 Participants
This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia
Brief behavioral treatment of insomnia (BBTI): The BBTI consists of a 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. The brief behavioral treatment component will focus on four behaviors that promote sleep through homeostatic, circadian, or association mechanisms. 50 These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
|
Information-only Control
n=27 Participants
This group is called information-only control. They will be provided sleep-related information. They will also view a video content of which overlap substantially with BBTI but without individualized behavioral instructions.
Information-only control (IC): The IC condition is intended to emulate the behavioral treatment information generally to available patients. It includes instructions to review hand out on healthy sleep practices. We will also use patient education videos on insomnia developed locally and widely used in clinical research. The content of these videos overlap substantially with BBTI but without individualized behavioral instructions. Two weeks later, IC participants will receive a 10-minute follow-up telephone call to encourage continued participation. Participants will be referred to the brochures for specific sleep-related questions.
|
|---|---|---|
|
Change in Duration of Uninterrupted Sleep
Pre-intervention
|
174 minutes, imputed from bladder diary
Standard Deviation 53
|
188 minutes, imputed from bladder diary
Standard Deviation 53
|
|
Change in Duration of Uninterrupted Sleep
Post-intervention
|
227 minutes, imputed from bladder diary
Standard Deviation 68
|
210 minutes, imputed from bladder diary
Standard Deviation 72
|
Adverse Events
Brief Behavioral Treatment for Insomnia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information-only Control
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