Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-02-25 @ 9:00 PM
Study NCT ID:
NCT01785303
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATRICS
Brief 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.
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.
Detailed Description:
OSA is a sleep-related breathing disorder that is growing in prevalence and is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. Insomnia is a frequently co-occurring sleep disorder that adds significant morbidity and is a potential barrier to adherence of OSA treatment. It is currently unknown if direct treatment of insomnia will enhance outcomes of OSA treatment. The investigators at the Rush Sleep Disorders Center have developed an approach that combines CBT for insomnia delivered by a psychologist with CPAP therapy managed by a physician. Building upon preliminary data collected in the clinic, the investigators seek to test the efficacy and mechanisms of this multidisciplinary model against the standard practice of treating OSA using CPAP alone.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: