Sleep FragmentationNCT03883724
Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
A study testing Brief behavioral treatment of insomnia (BBTI) in people with Sleep Fragmentation and Poor Quality Sleep, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Fragmentation, Poor Quality Sleep, Nocturia
- What is being tested?
- Brief behavioral treatment of insomnia (BBTI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ambulatory and functionally-independent community-dwelling men and women
- aged 65 years, or more
- with nocturia ≥2/night
- poor sleep because of frequent awakenings
Who cannot join
- Unstable or acute medical or central nervous system conditions
- Untreated, current, severe psychiatric condition
- Untreated, current, severe overactive bladder syndrome
- Post void residual > 30ml
- Sleep apnea with AHI≥15
- Currently diagnosed and/or treated Obstructive Sleep Apnea, Restless Legs Syndrome, parasomnia
Show all 9Show fewer
- Congestive heart failure, by exam or Beta natriuretic peptide (BNP)> 30 pmol/L
- Chronic kidney disease, stage III-V (eGFR<50)
- >14 alcohol drinks per week
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
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.
- Conditions
- Sleep Fragmentation, Poor Quality Sleep, Nocturia, Nocturnal Enuresis
- Being tested
- Brief behavioral treatment of insomnia (BBTI), Information-only control (IC)
- Keywords
- Nocturia, Poor sleep
- Medical subject headings
- Sleep Deprivation, Nocturia, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief behavioral treatment of insomnia (BBTI)Behavioural
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 (IC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief behavioral treatment for insomnia | Experimental | This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia Receives: Behavioral: Brief behavioral treatment of insomnia (BBTI) |
| Information-only control | Other | 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. Receives: Behavioral: Information-only control (IC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline nocturnal polyuria index at 4 weeks
Secondary outcomes (2)
Change in Nocturia
Nocturia=number of awakenings to void each night
Measured: 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
Measured: Change from baseline duration of uninterrupted sleep at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Feb 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep FragmentationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shachi Tyagi, University of Pittsburgh
- Investigators
- Shachi Tyagi, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883724
- Sponsor's protocol ID
- PRO18100572
- Other IDs
- R21AG060292
- Status last verified
- Nov 2022
- First submitted
- 12 Mar 2019
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
- ClinicalTrials.gov ID
- NCT03883724
- Acronym / sponsor ID
- PRO18100572
- Conditions
- Sleep Fragmentation, Poor Quality Sleep, Nocturia, Nocturnal Enuresis
- Keywords
- Nocturia, Poor sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Brief behavioral treatment for insomnia | Experimental | Behavioral: Brief behavioral treatment of insomnia (BBTI)This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia |
| Information-only control | Other | Behavioral: Information-only control (IC)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ambulatory and functionally-independent community-dwelling men and women
- aged 65 years, or more
- with nocturia ≥2/night
- poor sleep because of frequent awakenings
Key exclusion criteria (9 listed)
- Unstable or acute medical or central nervous system conditions
- Untreated, current, severe psychiatric condition
- Untreated, current, severe overactive bladder syndrome
- Post void residual > 30ml
- Sleep apnea with AHI≥15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Brief behavioral treatment for insomnia |
| 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. | Behavioural | Information-only control |
Primary outcome
Change in Nocturnal Polyuria Index
Time frame: change from baseline nocturnal polyuria index at 4 weeks
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
2 secondary outcomes
Change in Nocturia
Time frame: change from baseline nocturia episodes each night at 4 weeks
Change in Duration of Uninterrupted Sleep
Time frame: Change from baseline duration of uninterrupted sleep at 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sleep Fragmentation
Not yet recruiting
Acupuncture for Sleep Fragmentation in Older Adults: A Single-Arm Pilot Study
Sleep Fragmentation, Poor Sleep Quality
RecruitingPhase 1
The Role of the LC-NA System in Experimental Sleep Fragmentation
The Role of the LC-NA System in Sleep Regulation
Recruiting
Improving Sleep Quality During Pregnancy Using an Oral Appliance
Snoring, Sleep Fragmentation
Recruiting
Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)
Parkinson's Disease, Sleep Fragmentation
RecruitingObservational study
Apnea, Stroke and Incident Cardiovascular Events
Stroke, Sleep-disordered Breathing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shachi Tyagi, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief behavioral treatment of insomnia (BBTI) in people with Sleep Fragmentation and Poor Quality Sleep, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nocturnal Polyuria Index (time frame: change from baseline nocturnal polyuria index at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.