Status:
RECRUITING
Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Obstructive Sleep Apnea
Insomnia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Insomnia;
- Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.
Exclusion
- 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.
Key Trial Info
Start Date :
August 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06017921
Start Date
August 24 2023
End Date
December 20 2025
Last Update
March 19 2024
Active Locations (1)
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1
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, 55