Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/27/2019 |
| Start Date: | February 1, 2019 |
| End Date: | January 31, 2021 |
| Contact: | Shachi Tyagi, MD, MS |
| Email: | sht55@pitt.edu |
| Phone: | 412.647.1274 |
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.
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.
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.
Inclusion Criteria:
- ambulatory and functionally-independent community-dwelling men and women
- aged 65 years, or more
- with nocturia ≥2/night
- poor sleep because of frequent awakenings
Exclusion Criteria:
- 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
- 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
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-647-1274
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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