Medication targeting traits of obstructive sleep apnea
Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
This study is testing if certain medications can improve sleep for people with obstructive sleep apnea by comparing them to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06295562 on ClinicalTrials.gov |
What this trial studies
This study involves three intervention trials with 44 participants each, where half will receive medication and the other half a placebo before sleep. The medications being tested include atomoxetine combined with oxybutynin, venlafaxine, and atomoxetine combined with trazodone. Participants will undergo overnight polysomnography to assess changes in their apnea-hypopnea index and other sleep parameters. The goal is to evaluate the effectiveness of these pharmacological treatments on obstructive sleep apnea.
Who should consider this trial
Good fit: Ideal candidates are adults with an apnea-hypopnea index of 15 or higher.
Not a fit: Patients with severe medical or psychiatric conditions, or those currently using CPAP therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new medication options for patients suffering from obstructive sleep apnea.
How similar studies have performed: Other studies have explored pharmacological treatments for sleep apnea, but this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * apnea-hypopnea index ≥ 15 hr-¹ Exclusion Criteria: * the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases * current use of continuous positive airway pressure therapy * use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study * known allergy to the investigational medication * current smoking * heavy alcohol drinking (male \> 14 drinks and women \>7 drinks per week) * pregnant or lactating * periodic limb movement index ≤ 15hr-1 * the presence of sleep-related hypoventilation
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Cheng, Ph.D.
- Email: s871065@gmail.com
- Phone: +886422052121
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.