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

Phase 4

Recruiting

• Conditions: Insomnia; Obstructive Sleep Apnea
• Interventions: Drug: Placebo; Drug: Eszopiclone 3 mg

• Registration Number: NCT06017921
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-10
• Study Start: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo at bed time for 14 days
Eszopiclone	Eszopiclone 3 mg	Eszopiclone 3mg at bed time for 14 days

Primary Outcome Measures

Name	Time	Method
Short-term CPAP adherence (use > 4 hours per night through Resmed program)	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety	6 months	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.

Trial Locations

Locations (1)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo; 🇧🇷 Sao Paulo, Brazil