drugset / Trial / NCT03189173
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
Phase 2
Completed
41 enrolled
Brigham and Women's Hospital
American Heart Association · collabHeart Foundation of Australia · collabMonash University · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedSingle-groupDouble-blindTreatment
Summary
The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested: Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance. Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.
Timeline
- Start
- 2017-09-06
- Primary completion
- 2023-05-01
- Completion
- 2023-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxygen | Other / unclassified | 4 unknown | Other |