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Oxybutynin for Sleep Apnea

Phase 2
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

This trial tests if a combination of two medications, atomoxetine and oxybutynin, can reduce the severity of sleep apnea in patients with moderate-to-severe OSA. Previous studies have shown that the combination of atomoxetine and oxybutynin can significantly reduce the severity of obstructive sleep apnea (OSA). The drugs may help keep the airway open during sleep, reducing breathing interruptions and improving sleep quality.

Eligible Conditions
  • Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apnea-hypopnea index [AHI]
Secondary study objectives
Arousal index
Epworth Sleepiness Scale
Functional Outcomes of Sleep Questionnaire, Short Form
+2 more

Side effects data

From 2008 Phase 4 trial • 57 Patients • NCT00224016
18%
Infection
18%
Headache
15%
Urinary tract infection
15%
Fever
13%
Pharyngitis
13%
Rash
13%
Vomiting
10%
Pain
10%
Constipation
8%
Pain abdominal
8%
Pruritis
8%
Rhinitis
8%
Diarrhea
8%
Pain back
5%
VP shunt malfunction
5%
Skin ulcer
3%
Gastritis
3%
Knee wound dehiscence
3%
Worsening dehydration
3%
Tethered cord
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxybutynin TDS
Oral Oxybutynin

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Atomoxetine and OxybutyninExperimental Treatment2 Interventions
Participants will take Atomoxetine and Oxybutynin nightly for one month. Half doses will be given on the first three nights.
Group II: PlaceboPlacebo Group1 Intervention
Participants will take Placebos nightly for one month. Half doses will be given on the first three nights.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atomoxetine
FDA approved
Oxybutynin
FDA approved

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,160 Total Patients Enrolled
12 Trials studying Sleep Apnea
6,785 Patients Enrolled for Sleep Apnea
Scott A Sands, PhDPrincipal InvestigatorBrigham and Women's Hospital
6 Previous Clinical Trials
190 Total Patients Enrolled
1 Trials studying Sleep Apnea
23 Patients Enrolled for Sleep Apnea
~12 spots leftby Nov 2025
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