Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Menopause Clinical Trial

Official title:

Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933295
• Other study ID #: NR013959
• Secondary ID: R01NR013959-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.

Description:

Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.

Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.

Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).

Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• post-menopausal insomnia

Exclusion Criteria:

• unstable medical conditions

Related Conditions & MeSH terms

• Menopause

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia

• Sleep Education

• Sleep Restriction Therapy

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Christopher Drake	National Institute of Nursing Research (NINR), University of Michigan, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diary Based Sleepiness	Diaries were based on the consensus sleep diaries but were modified to also measure patient sleepiness over the past 24 hours on a 0 "none" to 10 "highest" scale. Scores in this study represent the daily mean for sleepiness ratings for each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)	8 months
Secondary	Fatigue Severity Scale (FSS).	Scores range from 9 to 63, with higher scores indicating greater fatigue, and scores above 36 indicate severe fatigue.; Data collected at pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline).	8 months
Secondary	Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale	Domain scores range from 0 to 100 with higher scores indicating better quality of life.; Data collected at each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)	8 months