An interventional study of Brief behavioral treatment of insomnia (BBTI) and Information-only control (IC) in Sleep Fragmentation, Poor Quality Sleep and Nocturia, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other
Among 146 studies in Sleep Deprivation with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Sleep Deprivation · United States.
Among the 146 studies in Sleep Deprivation with a site in United States, this one is the 63rd largest by enrollment of the 127 interventional ones that give a count, is one of 7 that started in 2019, is one of 104 with no phase, and was the 77th registered.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
Browse Sleep Deprivation studies →30 of the 146 studies in Sleep Deprivation with a site in United States are open now. Recruiting first, the newest first:
Harmony Biosciences Management, Inc. · Sites in United States
Ages 18–55 · Healthy volunteers
University of Pennsylvania · Sites in United States
Ages 21–60 · Healthy volunteers
University of Arizona · Sites in United States
Ages 18–55
Children's Hospital of Philadelphia · Sites in United States
Ages 13–18
University of Utah · Sites in United States
Ages 18–35 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 43 Sleep Deprivation studies recruiting now, 11 (26%) set no upper age limit and 28 (65%) stop at 75 or younger; 5 take children under 18; 29 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
146 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 9 · Phase 3 1 · Phase 4 7
First in 1999; this study’s year is marked. 7 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 56 is above the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Median enrollment 56 across the 127 interventional studies, 64 across the 19 observational. Of the 106 that completed or were terminated, 27 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 146 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 5 studies filed under Sleep Deprivation — fewer than ten, so there is no comparison to draw.
7 of the studies in Sleep Deprivation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06642246Children's Hospital of PhiladelphiaSleep Promotion and Pediatric Hypertension | 2026-11 |
| NCT06336525Brigham and Women's HospitalAdult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. | 2027-01-31 |
| NCT05393830Beth Israel Deaconess Medical CenterThe Effect of Sleep Loss on Emotion Regulation | 2027-04-01 |
| NCT05703347Children's Hospital of PhiladelphiaOptimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children | 2027-06 |
| NCT02945501U.S. Army Medical Research and Development CommandTranscranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep | 2027-06 |
Add all 7 to your calendar (.ics) → With an account.
Among the 146 studies in Sleep Deprivation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Nocturia is prevalent in older adults and it vastly reduces quality of life. Yet its treatment remains inadequate because its causes are not well understood, especially nocturnal polyuria or increased urine production at night. This study, which builds on the investigators' ongoing research, would be the first of its kind to explore the role of sleep in nighttime urine production. The findings will contribute important knowledge to guide development of better targeted and more effective therapy for this prevalent and morbid condition.
Prevalent, morbid, and costly ($61 billion/year in 2012), nocturia is a major problem, especially for older adults. It increases the risk of falls, fractures, depression, nursing home placement, and death. Yet management of nocturia remains inadequate. Most behavior and pharmacotherapies for nocturia focus on bladder-related etiologies, and it's most prevalent attribute nocturnal polyuria (NP), or increased urine production during sleep remains poorly understood and inadequately treated with little advancement over the last 50 years. Disruption of diurnal excretory pattern, with higher nighttime urine production is common in older adults. While studies in young adults show that sleep plays a critical role in regulating nighttime urine production, among older adults the role of poor sleep in NP is under-investigated.
Urine production follows a circadian pattern in which transition from wake to sleep is followed by a pronounced decrease in excretion of water, electrolytes and other osmotically active substances. Studies in young population have established that physiological urine production follows a circadian rhythm, which is regulated by diurnal variation in secretion of hormones controlling water and salt excretion such as arginine vasopressin, renin-angiotensin-aldosterone system, and atrial natriuretic peptide. Sleep deprivation blunts nocturnal surge of these hormones and consequently alter water and salt excretion thereby increase nighttime urine volume leading to NP.
Recent evidence suggests that poor sleep quality, frequent sleep interruptions especially in the first part of the night and shorter duration of first uninterrupted sleep period are associated with NP but its pathophysiology is not fully understood. Additionally, among older adults with poor sleep, the investigators have shown that a behavioral intervention directed solely towards sleep (BBTI- brief behavioral treatment of insomnia an efficacious multimodal behavioral treatment for insomnia) not only improves sleep, but also nocturia. Hence, the investigators postulate that sleep interruptions in the first part of the sleep impacts the hormonal regulation of nighttime urine production causing NP. In addition, the investigators postulate that interventions to prolong the first uninterrupted sleep period will decrease NP and hence nocturia.
The, aims of the present proposal are to: 1) examine the impact of BBTI on duration of the first of uninterrupted sleep period and NP in elderly with nocturia; and 2) establish NP and duration of first uninterrupted sleep as mechanisms by which BBTI impacts nocturia. The investigators' hypothesis is that BBTI improves nocturia not only by improving sleep, (and specifically, duration of the first uninterrupted sleep period), but also by decreasing NP.
To accomplish these goals the investigators will recruit 60 community dwelling adults (aged >65) with nocturia and NP. Sleep will be assessed subjectively with the Insomnia Severity Index and objectively by 7-day sleep diary and wrist actigraph. Concurrently the investigators will collect 3-day bladder diary data to document their voiding pattern and volume during day and night. Participants will be randomized to receive the 4-week behavioral sleep intervention BBTI by a trained therapist or an information control intervention. The participants will repeat the study measures post-intervention.
The study results will provide important insights into shared pathological mechanisms underlying poor sleep, nocturia and nighttime urine production.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia
Behavioral: Brief behavioral treatment of insomnia (BBTI)
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.
Behavioral: Information-only control (IC)
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.
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
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
Time frame: change from baseline nocturnal polyuria index at 4 weeks
Change in Nocturia
Nocturia=number of awakenings to void each night
Time frame: change from baseline nocturia episodes each night at 4 weeks
Change in Duration of Uninterrupted Sleep
Duration of uninterrupted sleep is the first uninterrupted sleep period before first awakening to void
Time frame: Change from baseline duration of uninterrupted sleep at 4 weeks
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
| Milestone | Brief Behavioral Treatment for Insomnia | Information-only Control |
|---|---|---|
| Started | 29 | 27 |
| Completed | 29 | 27 |
| Not completed | 0 | 0 |
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
| percentage of urine volume | Brief Behavioral Treatment for Insomnia | Information-only Control |
|---|---|---|
| Pre-intervention | 41.7 ± 9.9 | 41.7 ± 10.1 |
| Post-intervention | 34.5 ± 13 | 37.8 ± 8.6 |
Nocturia=number of awakenings to void each night
| awakenings, as reported on bladder diary | Brief Behavioral Treatment for Insomnia | Information-only Control |
|---|---|---|
| Pre-intervention | 2.3 ± .6 | 2.1 ± .7 |
| Post-intervention | 1.3 ± .6 | 1.8 ± .6 |
Duration of uninterrupted sleep is the first uninterrupted sleep period before first awakening to void
| minutes, imputed from bladder diary | Brief Behavioral Treatment for Insomnia | Information-only Control |
|---|---|---|
| Pre-intervention | 174 ± 53 | 188 ± 53 |
| Post-intervention | 227 ± 68 | 210 ± 72 |
Collected over Adverse event data was collected over the duration of study participation for each participant, 6-8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Information-only Control | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
Overall, 56 participants were eligible, 29 randomized to BBTI and 27 to control group
| Age, Categorical(Participants) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 29 | 27 | 56 |
| Sex: Female, Male(Participants) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| Female | 20 | 16 | 36 |
| Male | 9 | 11 | 20 |
| Race (NIH/OMB)(Participants) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 7 |
| White | 26 | 23 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BMI(kg/m2) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| Mean | 27.2 ± 5.7 | 28.4 ± 5.1 | 27.8 ± 5.4 |
| Post void residual(ml) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| Mean | 11.6 ± 18.5 | 19.3 ± 28.8 | 15.2 ± 24 |
| Creatinine(mg/dL) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| Mean | 0.86 ± 0.21 | 0.94 ± 0.23 | 0.9 ± 0.2 |
| Calcium channel blocker(Participants) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| Count of participants | 3 | 4 | 7 |
| Beta-blocker(Participants) | Brief Behavioral Treatment for Insomnia | Information-only Control | Total |
|---|---|---|---|
| Count of participants | 2 | 7 | 9 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2019 to primary completion in Nov 2021, 33 months.
Results were first posted in Dec 2022, 1 year after primary completion.
Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's 33 months is above that.
Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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