drugset / Trial / NCT05293600

Rescue Pharmacotherapy for OSA

NCT05293600

Phase 1/2 Recruiting 70 enrolled Brigham and Women's Hospital
RandomizedCrossoverQuadruple-blindTreatment

Summary

Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of undertreated OSA. In this study, the investigators want to test the addition of a drug treatment to their regimen. Endotypes will be targeted pharmacologically with one of the following drugs: acetazolamide for a high loop gain, atomoxetine-plus-eszopiclone for poor pharyngeal muscle compensation, or trazodone for a low arousal threshold. This aim is expected to provide treatment strategies for rescuing non-responders to MAD or HGNS therapy.

Timeline

Start
2023-07-01
Primary completion
2026-10-30
Completion
2026-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetazolamide Small molecule 500 mg
Comparator Atomoxetine Other / unclassified 80 mg
Comparator Eszopiclone Small molecule 3 mg
Comparator Trazodone Small molecule 100 mg