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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

Study Summary

This trial is studying a combination of two drugs, atomoxetine and oxybutynin, to see if it improves sleep apnea severity and if patients exhibit signs of symptomatic relief.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apnea-hypopnea index [AHI]
Secondary outcome measures
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

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
1,622 Previous Clinical Trials
11,468,682 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
~13 spots leftby Jun 2025
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