Clinical trial NCT01785303: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
Official title: Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Insomnia
Keywords: CBT
CPAP
Multidisciplinary Treatment
Combination treatment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Stanford University
name: National Jewish Health
name: Rush University Medical Center
First posted: 2013-02-07
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: CPAP adherence
timeFrame: 90 days after CPAP initiation
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 90 days after CPAP initiation
Secondary outcomes:
measure: Polysomnography (PSG)
timeFrame: End of phase 1 (1 month after baseline assessment)
measure: Insomnia Severity Index (ISI)
timeFrame: 90 days after CPAP initiation
measure: Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 90 days after CPAP initiation
measure: Actigraphy
timeFrame: 90 days after CPAP initiation
Other outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: 90 days after CPAP initiation
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 90 days after CPAP initiation
Locations:
city: Chicago
country: United States
facility: Center for Circadian and Sleep Medicine, Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Jason Ong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tu AY, Crawford MR, Dawson SC, Fogg LF, Turner AD, Wyatt JK, Crisostomo MI, Chhangani BS, Kushida CA, Edinger JD, Abbott SM, Malkani RG, Attarian HP, Zee PC, Ong JC. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022 Mar 1;18(3):789-800. doi: 10.5664/jcsm.9696.