Atomoxetine and DAW2020 for treating obstructive sleep apnea
Effect of Atomoxetine and DAW2022 on OSA Severity
This study is testing if a combination of two medications can help people with obstructive sleep apnea breathe better while they sleep.
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 | NCT05350215 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of atomoxetine and DAW2020 on the severity of obstructive sleep apnea (OSA). Participants will undergo two overnight sleep studies, one with the drug combination and one with a placebo, to monitor sleep and respiratory variables. The study aims to assess the efficacy of these medications in reducing OSA severity while minimizing side effects associated with previous treatments. A thorough medical history and physical examination will be conducted prior to each study night.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed 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 significant respiratory disorders, major organ system diseases, or those on 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 moderate-to-severe obstructive sleep apnea.
How similar studies have performed: Previous studies have shown promising effects of atomoxetine and oxybutynin on OSA severity, but this specific combination with DAW2020 is novel and has not been extensively tested.
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, MD, PhD
- Email: lmessineo@bwh.harvard.edu
- Phone: 18572726188
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.