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

University of Sao Paulo General Hospital60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea Insomnia

Interventions

Eszopiclone 3 mgDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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