MedTrace Logo

Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea

NCT05944965 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-17

No results posted yet for this study

Summary

Current therapies available for obstructive sleep apnea (OSA) have varying degrees of efficacy due to the complex nature of the disorder. A reduction in pharyngeal muscle activity characterizes OSA, and recent research has shown that combining atomoxetine and oxybutynin improves OSA severity. Thus this may be a viable treatment option. However, the specific effects of these agents alone and in combination on pharyngeal muscle activity remain unknown. The current study will look at the impact of each drug on pharyngeal muscles to gain insight into the mechanisms of this combination.

Conditions

  • OSA

Interventions

DRUG

Placebo

Placebo and placebo (sugar pill) administered 30 mins prior to bed

DRUG

Atomoxetine 80 mg plus Oxybutynin 5 mg

80mg Atomoxetine and 5mg Oxybutynin administered 30mins prior to bed

DRUG

Atomoxetine 80 MG

80mg Atomoxetine administered 30 mins prior to bed

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Dillon Gilbertson · Brigham and Women's Hospital and Harvard Medical School

  • Scott A Sands, PhD · Brigham and Women's Hospital and Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-06-17
Completion
2025-06-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944965 on ClinicalTrials.gov