Effect of Trazodone on Obstructive Sleep Apnea
Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity
This study tests if taking trazodone before bed can help people with obstructive sleep apnea sleep better compared to a placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06286189 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of trazodone on patients with obstructive sleep apnea (OSA) by conducting two overnight home sleep studies, one with trazodone and one with a placebo. Participants will be monitored using full polygraphy to assess sleep and respiratory events without the use of CPAP. Trazodone will be administered 30 minutes before sleep to evaluate its effects on OSA traits and severity. A washout period will allow for a crossover to the alternative treatment after the initial study.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderate-to-severe obstructive sleep apnea, characterized by an apnea-hypopnea index (AHI) of 15 events per hour or more.
Not a fit: Patients with other sleep disorders, significant medical conditions, or those taking medications that affect respiration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with obstructive sleep apnea, potentially improving their sleep quality and overall health.
How similar studies have performed: While the use of trazodone for sleep disorders is known, this specific application in obstructive sleep apnea is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Moderate-to-severe OSA (AHI ≥ 15 events/hr) Exclusion Criteria: * All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements. * Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid). * Use of SNRIs/SSRIs. * Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition. * Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: * Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias. * Hypersensitivity to the study drug (angioedema or urticaria) * Contraindications to DAW2020 * Use of medications that lengthen QTc interval * Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease * Severe claustrophobia.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Ludovico Messineo
- Email: lmessineo@bwh.harvard.edu
- Phone: (617) 732-4013
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.