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Obstructive Sleep Apnea | Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

Obstructive Sleep Apnea research study

What is the primary objective of this study?

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 is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Obstructive Sleep Apnea

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:CBT-ICognitive Behavior Therapy for Insomnia (CBT-I) consists of 4 weekly sessions delivered individually. The focus of these sessions is on modifying behaviors and cognitions related to sleep and insomnia.

Procedure:CPAPCPAP is an FDA-approved medical device used to treat obstructive sleep apnea. This device consists of a mask, hose, and machine that blows continuous air which maintains a consistent pressure of airflow preventing the upper airway from collapsing during sleep.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Model AModel A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.

Model BModel B consists of 4 weeks of monitoring using sleep diaries in Phase I. Phase II consists of concurrent initiation of CBT-I and CPAP for OSA.

Model CModel C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.

Study Status

Recruiting

Start Date: February 2013

Completed Date: December 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: CPAP adherence

Secondary Outcome: Polysomnography (PSG)

Study sponsors, principal investigator, and references

Principal Investigator: Jason Ong, PhD

Lead Sponsor: Northwestern University

Collaborator: Stanford University

More information:https://clinicaltrials.gov/show/NCT01785303

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