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Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

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ClinicalTrials.gov Identifier: NCT03883724
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Shachi Tyagi, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
Change in Nocturnal Polyuria Index [ Time Frame: change from baseline nocturnal polyuria index at 4 weeks ]
Nocturnal Polyuria Index (NPI) is the proportion 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Change in Nocturnal Polyuria Index [ Time Frame: change from baseline nocturnal polyuria index at 4 weeks ]
Nocturnal Polyuria Index=nocturnal urine volume /24-hour urine volume
Change History Complete list of historical versions of study NCT03883724 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Change in nocturia [ Time Frame: change from baseline nocturia episodes each night at 4 weeks ]
    Nocturia=number of awakenings to void each night
  • change in duration of uninterrupted sleep [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Change in nocturia [ Time Frame: change from baseline nocturia episodes each night at 4 weeks ]
    Nocturia=number of awakenings to void each night
  • change in duration of uninterrupted sleep [ Time Frame: Change from baseline duration of uniterrupted sleep at 4 weeks ]
    Duration of uniterrupted sleep is the first uninterrupted sleep period before first awakening to void
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
Official Title  ICMJE Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Sleep Fragmentation
  • Poor Quality Sleep
  • Nocturia
  • Nocturnal Enuresis
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Brief behavioral treatment for insomnia
    This group will undergo behavioral intervention proven to improve sleep among older adults: brief behavioral treatment for insomnia
    Intervention: Behavioral: Brief behavioral treatment of insomnia (BBTI)
  • 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.
    Intervention: Behavioral: Information-only control (IC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shachi Tyagi, MD, MS 412.647.1274 sht55@pitt.edu
Contact: Kandy Newell, RN 412.647.1271 kln40@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03883724
Other Study ID Numbers  ICMJE PRO18100572
R21AG060292 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shachi Tyagi, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Shachi Tyagi, MD, MS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP