Understanding the Sleep Apnea/Insomnia Interaction

Study Overview
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Brief Summary
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Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.

Official Title
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Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial

Conditions
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Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Device: CPAP
* Behavioral: CBT
* Device: sham CPAP
* Behavioral: CC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sleep Apnea Insomnia Age >18 Exclusion Criteria: Sedative/psychoactive drug use recently Other clinically significant sleep disorders Previous treatment for obstructive sleep apnea (OSA) Requires oxygen or bilevel PAP therapy Clinically unstable medical condition Recent shift work Significant alcohol use Other clinically significant causes of insomnia Illicit drug use Prescription stimulants Safety restrictions Unable to treat sleep apnea with positive airway pressure therapy Communication barriers Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP+CC<br>Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia) | Device: CPAP<br>* Treatment for sleep apnea<br>* Other names: Continuous positive airway pressure therapy;Behavioral: CC<br>* Placebo (sham) for insomnia<br>* Other names: Contact control;|
| Sham Comparator: sham CPAP+CC<br>sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) | Device: sham CPAP<br>* Placebo for sleep apnea<br>* Other names: Sham (placebo) continuous positive airway pressure;Behavioral: CC<br>* Placebo (sham) for insomnia<br>* Other names: Contact control;|
| Active Comparator: CPAP+CBT<br>CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia | Device: CPAP<br>* Treatment for sleep apnea<br>* Other names: Continuous positive airway pressure therapy;Behavioral: CBT<br>* Treatment for insomnia<br>* Other names: Cognitive-Behavioral Therapy for Insomnia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index Score | Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score. | Between Baseline and Day 42. |