Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA

Study Overview
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Brief Summary
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The comorbidity between obstructive sleep apnea (OSA) and insomnia (COMISA) is common, and associated with poorer sleep quality. CPAP adherence among COMISA patients is worst than among those with OSA only. The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months.

Detailed Description
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The comorbidity between OSA and insomnia (COMISA) is common. COMISA leads to additive impairment of quality of sleep and quality of life compared to patients with insomnia or OSA alone. Patients with COMISA demonstrate worse adherence to CPAP compared to patients with isolated OSA. The best therapeutic approach for patients with COMISA is still unclear. Hypnotics have not been tested among patients with COMISA and indication for CPAP. The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months. In addition, the investigators will assess the effect eszopiclone on insomnia severity, quality of life, anxiety.

Official Title
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Effect of Eszopiclone on Adherence to Continuous Positive Airway Pressure (CPAP) and Severity of Insomnia in Patients With Comorbidity Between Insomnia and Obstructive Sleep Apnea (COMISA)

Conditions
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Obstructive Sleep Apnea, Insomnia

Intervention / Treatment
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* Drug: Eszopiclone 3 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Insomnia; Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography. Exclusion Criteria: Craniofacial anatomical abnormalities or severe otorhinolaryngological disorders that potentially impair CPAP use; Use of hypnotics for more than 7 days in the last 2 months; Renal dysfunction (serum creatinine >2mg/dL); Severe liver or cardiac dysfunction; Alcoholism; Previous CPAP or mandibular advancement device for OSA treatment in the last 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Eszopiclone<br>Eszopiclone 3mg at bed time for 14 days | Drug: Eszopiclone 3 mg<br>* Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm<br>|
| Placebo Comparator: Placebo<br>Placebo at bed time for 14 days | Drug: Placebo<br>* Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term CPAP adherence (use > 4 hours per night through Resmed program) | Compare the effect of Eszopiclone 3mg or placebo for 14 days on one-month CPAP adherence (use > 4 hours per night through Resmed program) after 4 weeks days. Adherence to CPAP will be assess by the average number of hours of use (>=4h). The investigators will use Resmed's program for this analysis. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety | Compare the effect of Eszopiclone 3mg or placebo for 14 days on 6 months CPAP adherence (use > 4 hours per night through Resmed program), sleep quality, insomnia and anxiety through questionnaries. Adherence to CPAP will be assess by the average number of hours of use (>=4h). The investigators will use Resmed's program for this analysis. The sleep quality, insomnia and anxiety will be assess through questionnaires. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COMISA, Obstructive Sleep Apnea