CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Brief behavioral treatment of insomnia (BBTI) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03883724
NCT03883724N/ACompleted

Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

University of Pittsburgh·interventional·Posted Mar 21, 2019·Updated Dec 22, 2022

In Brief

A clinical study evaluating Brief behavioral treatment of insomnia (BBTI) and Information-only control (IC) for Sleep Fragmentation and 3 related conditions. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartFeb 1, 2019
Primary CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.3 years ago

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.

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.