NCT06017921

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstructive Sleep Apnea
• Insomnia

Interventions

Type	Name	Description
DRUG	Eszopiclone 3 mg	Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
DRUG	Placebo	Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Timeline

• Start date: 2023-08-24
• Primary completion: 2025-03-20
• Completion: 2025-12-20
• First posted: 2023-08-30
• Last updated: 2024-03-19

Locations

1 site across 1 country: Brazil