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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• Clinical diagnosis of Insomnia;
• Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.
Locations
Other Locations
Brazil
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Pedro R Genta, MD.
prgenta@usp.br
551126615486
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 60
Treatments
Active_comparator: Eszopiclone
Eszopiclone 3mg at bed time for 14 days
Placebo_comparator: Placebo
Placebo at bed time for 14 days
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital