Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— MATRICS  

Official title:

Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785303
• Other study ID #: 1R01HL114529-01
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: February 2019

Study information

• Verified date: March 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Insomnia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• CBT-I
Cognitive 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:
• CPAP
CPAP 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.

Locations

Country	Name	City	State
United States	Center for Circadian and Sleep Medicine, Northwestern University	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	National Jewish Health, Rush University Medical Center, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatigue Severity Scale (FSS)	Improvement in FSS from baseline to 90 days after CPAP initiation (End of Phase II).	90 days after CPAP initiation
Other	Epworth Sleepiness Scale (ESS)	Improvement in ESS from baseline to 90 days after CPAP initiation.	90 days after CPAP initiation
Primary	CPAP adherence	CPAP adherence is defined as % nights used and hrs per night and % of "good users" (= 4 hours on = 70% of nights)	90 days after CPAP initiation
Primary	Pittsburgh Sleep Quality Index (PSQI)	Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.	90 days after CPAP initiation
Secondary	Polysomnography (PSG)	Improvement in PSG sleep efficiency at the end of Phase I	End of phase 1 (1 month after baseline assessment)
Secondary	Insomnia Severity Index (ISI)	Improvement in ISI from baseline to 90 days after CPAP initiation	90 days after CPAP initiation
Secondary	Functional Outcomes of Sleep Questionnaire (FOSQ)	Improvement in FOSQ from baseline to 90 days after CPAP initiation	90 days after CPAP initiation
Secondary	Actigraphy	Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.	90 days after CPAP initiation