Effect of Eszopiclone on CPAP adherence and 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)
This study tests if the sleep medication Eszopiclone can help people with both sleep apnea and insomnia stick to their CPAP therapy and sleep better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (Sao Paulo) |
| Trial ID | NCT06017921 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Eszopiclone, a sleep medication, on improving adherence to CPAP therapy and reducing insomnia severity in patients with comorbid obstructive sleep apnea and insomnia (COMISA). Participants will receive either Eszopiclone 3mg or a placebo for 14 days, with follow-up assessments on CPAP adherence after 30 days and 6 months. The study aims to clarify the therapeutic approach for patients suffering from both conditions, as they typically experience worse sleep quality and quality of life. Additionally, the study will evaluate changes in insomnia severity, quality of life, and anxiety levels.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with moderate to severe obstructive sleep apnea and insomnia.
Not a fit: Patients with craniofacial abnormalities, severe medical conditions, or those who have used hypnotics recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance CPAP adherence and improve sleep quality for patients suffering from both obstructive sleep apnea and insomnia.
How similar studies have performed: While the use of hypnotics in this specific patient population is novel, other studies have explored CPAP adherence in OSA patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sao Paulo
- Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo — Sao Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Pedro R Genta, MD.
- Email: prgenta@usp.br
- Phone: 551126615486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.