M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)

Status unconfirmed · Not applicable

Conditions studied: Insomnia, Morbid Obesity

In brief

This study is a longitudinal clinical trial designed to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with insomnia following bariatric surgery.

Key facts

Study ID

NCT04619771

Run by

Stony Brook University

People needed

20

Starts

2021-01-01

Expected to finish

2022-02-01

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-64
• Fluency with English
• Willingness to maintain an active telehealth platform account
• Daily access to wireless internet connection or sufficient cell phone service for telemedicine
• Undergone bariatric surgery (Roux-en-Y or vertical sleeve gastrectomy) within past 1-3 years
• Must have experienced <50% excess weight loss following surgery Clinically significant insomnia (i.e., ISI score >11)

You may not qualify if…

• Patient underwent revision of initial weight loss procedure
• PHQ-9 Depression score > 15
• GAD-7 Anxiety score > 15
• Current alcohol or substance abuse
• Current narcotic use
• Unstable major psychiatric condition
• Restless leg syndrome
• Sleep apnea with non-adherence to CPAP intervention (i.e., use of CPAP <4 nights/week)
• Other problems at investigator discretion
• Vulnerable populations (e.g., adults unable to consent, ages <18, pregnant women, and prisoners).

Where it is running

• Stony Brook University — Stony Brook, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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