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Atomoxetine + Oxybutynin for Obstructive Sleep Apnea

Phase 1 & 2

Waitlist Available

Led By Scott A Sands, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed OSA (AHI≥15 events/h reported in PSG performed within one year) or Suspected OSA (snoring, sleepiness, witness apneas, other clinical symptoms)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 night

Awards & highlights

Study Summary

This trial will explore the potential of a combination of two drugs to improve obstructive sleep apnea severity. Results will reveal the effects of these drugs on pharyngeal muscles.

Who is the study for?

This trial is for adults with diagnosed or suspected obstructive sleep apnea (OSA) who are not currently using CPAP therapy. People with neuromuscular diseases, heart failure, other major medical conditions, or those taking certain medications that affect respiration or have contraindications to the study drugs cannot participate.Check my eligibility

What is being tested?

The study tests how well Atomoxetine (80 mg), Oxybutynin (5 mg), and their combination improve muscle control in the throat for OSA patients compared to a placebo. It aims to understand if these drugs can be an effective treatment by studying their individual and combined effects.See study design

What are the potential side effects?

Possible side effects of Atomoxetine may include dry mouth, trouble sleeping, decreased appetite, increased blood pressure and heart rate. Oxybutynin might cause dry mouth, constipation, dizziness and blurred vision. The combination could potentially amplify these effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with severe sleep apnea or suspect I have it due to symptoms like snoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 night

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 night

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peak Genioglossus Activity

Tensor Palatini Activity

Ventilation

Secondary outcome measures

Muscle Effectiveness (V-Drive slope)

Peak genioglossus responsiveness (GG-Drive slope)

Peak genioglossus, baseline activation, i.e. at eupneic ventilatory drive (GGpassive)

+3 more

Other outcome measures

Arousal Threshold

Loop Gain

Tonic genioglossus activity, unadjusted for ventilatory drive (GGtonic,min)

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Atomoxetine-plus-Oxybutynin (AtoOxy)Experimental Treatment1 Intervention

80mg atomoxetine and 5mg of oxybutynin administered to participant, 30 min prior to bed.

Group II: AtomoxetineActive Control1 Intervention

80mg atomoxetine and placebo administered to participant, 30 min prior to bed.

Group III: PlaceboPlacebo Group1 Intervention

Placebo plus placebo administered to participant, 30mins prior to bed

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,470,302 Total Patients Enrolled

Dillon GilbertsonStudy DirectorBrigham and Women's Hospital and Harvard Medical School

2 Previous Clinical Trials

72 Total Patients Enrolled

Scott A Sands, PhDPrincipal InvestigatorBrigham and Women's Hospital and Harvard Medical School

6 Previous Clinical Trials

240 Total Patients Enrolled

Media Library

Atomoxetine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05944965 — Phase 1 & 2

Obstructive Sleep Apnea Research Study Groups: Placebo, Atomoxetine-plus-Oxybutynin (AtoOxy), Atomoxetine

Obstructive Sleep Apnea Clinical Trial 2023: Atomoxetine Highlights & Side Effects. Trial Name: NCT05944965 — Phase 1 & 2

Atomoxetine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05944965 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open?

"According to the records on clinicaltrials.gov, this trial is not currently recruiting patients. The research was first published in September of 2023 and updated lastly in July of the same year. Despite that, there are 216 different trials actively searching for participants at present time."

Answered by AI

Is it possible to be enrolled in this clinical experiment?

"Prospective participants need to suffer from obstructive sleep apnea and must be aged between 21 and 70. Up to 25 applicants are eligible for enrollment in this clinical trial."

Answered by AI

What research objectives is this study hoping to accomplish?

"This nocturnal clinical trial is designed to assess Tensor Palatini Activity as its primary outcome. Secondary objectives include measuring the responsiveness of Tensor palatini (TP-Drive slope), ventilation at eupneic ventilatory drive indicating collapsibility (Vpassive), and Muscle Effectiveness (V-Drive slope) for functional pharyngeal airway mechanical improvement."

Answered by AI