drugset / Trial / NCT03919955
A Novel Pharmacological Therapy for Obstructive Sleep Apnea
Phase 2
Completed
117 enrolled
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
A pharmacological, non-mechanical therapy for OSA that is efficacious and tolerable remains elusive. Here the investigators study the effect on sleep apnea severity of a combination of pharmacological agents (atomoxetine and oxybutynin, "AtoOxy") over a 1 month period of time. The current study will answer the following questions: Does ongoing, repeated-dose administration of atomoxetine-plus-oxybutynin (referred to as "AtoOxy") improve OSA severity, and do patients exhibit signs of symptomatic relief? Most importantly, which phenotypic subgroup of patients preferentially benefit from this intervention?
Timeline
- Start
- 2019-09-03
- Primary completion
- 2023-09-07
- Completion
- 2023-09-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atomoxetine | Other / unclassified | 80 mg | Oral |
| Subject | Oxybutynin | Small molecule | 5 mg | Oral |