Last updated 9 months ago
Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA
60 patients around the world
Available in Brazil
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.
University of Sao Paulo General Hospital
1Research sites
60Patients around the world
This study is for people with
Sleep disorders
Sleep apnea
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Clinical diagnosis of Insomnia;Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.
- 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.
Sites
Instituto do Coração do HCFMUSP
Recruiting
SponsorUniversity of Sao Paulo General Hospital
Conditions
Sleep apnea
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06017921
