CompletedNot Applicable

Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

United States121 participantsStarted 2013-02

Plain-language summary

The overall goal of this project is to determine the efficacy of a multidisciplinary treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia. Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive Behavioral Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with OSA and comorbid insomnia. Specific Aim 2: To determine if there are relative benefits in the sequence of treatment initiation. Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and Females age 18 and older. * Meets criteria for Obstructive Sleep Apnea * Meets criteria for an Insomnia Disorder Exclusion Criteria: * Comorbid medical condition that requires immediate treatment of OSA * Severe cases of OSA that require immediate treatment * Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment * Comorbid sleep disorders that require treatment outside of the study protocol * Other sleep-related breathing disorder besides OSA * Excessive daytime sleepiness that requires immediate treatment or presents significant risk * CPAP use or formal CBT for insomnia within the past 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CPAP adherence

Timeframe: 90 days after CPAP initiation

Pittsburgh Sleep Quality Index (PSQI)

Timeframe: 90 days after CPAP initiation

Trial details

NCT IDNCT01785303

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials