Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

NCT03883724 | Completed Results

• 2 other identifiers: PRO18100572R21AG060292
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Fragmentation; Poor Quality Sleep; Nocturia; Nocturnal Enuresis

Keywords

Nocturia; Poor sleep

Outcome Measures

Primary Outcomes (1)

• 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

  change from baseline nocturnal polyuria index at 4 weeks

Secondary Outcomes (2)

• Change in Nocturia

  change from baseline nocturia episodes each night at 4 weeks

• Change in Duration of Uninterrupted Sleep

  Change from baseline duration of uninterrupted sleep at 4 weeks

Study Arms (2)

Brief behavioral treatment for insomnia

EXPERIMENTAL

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)

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.

Behavioral: Information-only control (IC)

Interventions

Brief behavioral treatment of insomnia (BBTI) BEHAVIORAL

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.

Brief behavioral treatment for insomnia

Information-only control (IC) BEHAVIORAL

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.

Information-only control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ambulatory and functionally-independent community-dwelling men and women
• aged 65 years, or more
• with nocturia ≥2/night
• poor sleep because of frequent awakenings

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Nocturia; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders

Results Point of Contact

• Title: Shachi Tyagi
• Organization: UPittsburgh

sht55@pitt.edu

4126471274

Study Officials

• Shachi Tyagi, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 21, 2019
• Study Start: February 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Locations

US (1)