CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Atomoxetine +2 moredrug
Likely dose
Atomoxetine 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03919955
NCT03919955Phase 2Completed

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

Brigham and Women's Hospital·interventional·Posted Apr 18, 2019·Updated Dec 23, 2025

In Brief

A Phase 2 clinical trial evaluating Atomoxetine, Oxybutynin, and 1 other intervention for Sleep Apnea. Completed, enrolled 117 participants across 1 site.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartSep 3, 2019
Primary CompletionSep 7, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.2 years ago

Interventions

Atomoxetinedrug

Atomoxetine 80 mg, per mouth, before bed. Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.

Oxybutynindrug

Oxybutynin 5 mg, per mouth, before bed. Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.

Placebodrug

Placebo, per mouth, before bed.Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.