Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

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

Interventions

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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Shachi Tyagi, MD, MS · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-02-01

Primary Completion

2021-11-30

Completion

2021-11-30

Countries

• United States

Study Locations