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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-24

Study Completion Date

2025-12-20

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.

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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.

Conditions

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Obstructive Sleep Apnea Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

double-blind

Study Groups

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Eszopiclone

Eszopiclone 3mg at bed time for 14 days

Group Type ACTIVE_COMPARATOR

Eszopiclone 3 mg

Intervention Type DRUG

Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Placebo

Placebo at bed time for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Interventions

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Eszopiclone 3 mg

Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Intervention Type DRUG

Placebo

Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes