Insomnia, Obstructive Sleep Apnea
Conditions
Keywords
CBT, CPAP, Multidisciplinary Treatment, Combination 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.
Interventions
BEHAVIORALCBT-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.
PROCEDURECPAP
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.
Sponsors
Stanford University
National Jewish Health
Rush University Medical Center
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP adherence | 90 days after CPAP initiation | CPAP adherence is defined as % nights used and hrs per night and % of good users (≥ 4 hours on ≥ 70% of nights) |
| Pittsburgh Sleep Quality Index (PSQI) | 90 days after CPAP initiation | Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 90 days after CPAP initiation | Improvement in ISI from baseline to 90 days after CPAP initiation |
| Actigraphy | 90 days after CPAP initiation | Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation. |
| Functional Outcomes of Sleep Questionnaire (FOSQ) | 90 days after CPAP initiation | Improvement in FOSQ from baseline to 90 days after CPAP initiation |
| Polysomnography (PSG) | End of phase 1 (1 month after baseline assessment) | Improvement in PSG sleep efficiency at the end of Phase I |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale (FSS) | 90 days after CPAP initiation | Improvement in FSS from baseline to 90 days after CPAP initiation (End of Phase II). |
| Epworth Sleepiness Scale (ESS) | 90 days after CPAP initiation | Improvement in ESS from baseline to 90 days after CPAP initiation. |
Countries
United States
Outcome results
None listed