Adults with moderate-to-severe obstructive sleep apnea and low respiratory arousal threshold who are initiating CPAP therapy for the first time Obstructive Sleep Apnea Continuous Positive Airway Pressure Treatment Adherence and Compliance Orexin Receptor Antagonist
Conditions
Interventions
Participants will receive Lemborexant 5 mg orally once daily immediately before bedtime for 14 consecutive days after initiation of CPAP therapy. Participants will also receive standard CPAP treatment
Experimental Drug,Placebo Comparator Drug
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age at least 18 years old 2. Moderate-to-severe OSA 3. Low respiratory arousal threshold identified using validated clinical criteria 4. Planned initiation of CPAP therapy without previous CPAP use. 5. Ability to comply with study procedures with written informed consent
Exclusion criteria
Exclusion criteria: 1. Central sleep apnea or other significant sleep disorders 2. Use of sedative and hypnotics within 14 days. 3. Use of moderate to strong CYP3A inhibitors or strong CYP3A inducers within 14 days 4. Severe cardiopulmonary disease 5. Uncontrolled psychiatric disorders 6. Hypersensitivity to Lemborexant 7. Contraindication for Lemborexant eg. Narcolepsy, severe hepatic impairment. 8. Pregnancy or breastfeeding 9. CPAP intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average nightly CPAP usage at 1 month after CPAP initiation hours/night | — |
Secondary
| Measure | Time frame |
|---|---|
| Nights with CPAP use at least 4 hours at 14 days and 1 month after CPAP initiation Percentage,Average CPAP usage on nights used at 14 days and 1 month after CPAP initiation hours/night,Nights CPAP used at 14 days and 1 month after CPAP initiation Percentage,Residual AHI at 14 days and 1 month after CPAP initiation events/hour,Insomnia Severity Index (ISI) at 14 days and 1 month after CPAP initiation ISI score,Epworth Sleepiness Scale (ESS) at 14 days and 1 month after CPAP initiation ESS score,Functional Outcomes of Sleep Questionnaire (FOSQ) at 14 days and 1 month after CPAP initiation FOSQ score,Pittsburgh Sleep Quality Index (PSQI) at 1 month after CPAP initiation PSQI score,Mask leak at 14 days and 1 month after CPAP initiation Liters/minute,Adverse events at 14 days and 1 month after CPAP initiation events | — |
Countries
Thailand
Contacts
Public ContactSasicha Kwanloetchit
Division of Pulmonary and Critical Care Medicine, King Chulalongkorn Memorial Hospital
Outcome results
None listed