Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

Not Applicable

Completed

Conditions: Nocturnal Enuresis
Poor Quality Sleep
Nocturia
Sleep Fragmentation

Interventions: Behavioral: Brief behavioral treatment of insomnia (BBTI)
Behavioral: Information-only control (IC)

Registration Number: NCT03883724

Lead Sponsor: University of Pittsburgh

Brief 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. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief behavioral treatment for insomnia	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	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.

Primary Outcome Measures

Name	Time	Method
Change in Nocturnal Polyuria Index	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

Secondary Outcome Measures

Name	Time	Method
Change in Nocturia	change from baseline nocturia episodes each night at 4 weeks	Nocturia=number of awakenings to void each night
Change in Duration of Uninterrupted Sleep	Change from baseline duration of uninterrupted sleep at 4 weeks	Duration of uninterrupted sleep is the first uninterrupted sleep period before first awakening to void