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Atomoxetine + Oxybutynin for Sleep Apnea

Phase 1 & 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
Recent drug induced sleep endoscopy results available (performed as part of routine clinical care)
Suspected or diagnosed OSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial finds that people with sleep apnea who have certain pathophysiological traits respond better to Atomoxetine-plus-oxybutynin therapy.

Who is the study for?
This trial is for people with suspected or diagnosed obstructive sleep apnea who have recent drug-induced sleep endoscopy results. It's not for those with uncontrolled medical conditions, other major respiratory disorders, using certain medications like hypnotics or SSRIs, pregnant or nursing women, and individuals with a range of specific health issues such as severe hypertension, heart failure, liver/kidney disease.Check my eligibility
What is being tested?
The study tests whether Atomoxetine-plus-oxybutynin therapy (AtoOxy) effectively reduces the severity of obstructive sleep apnea in patients. Researchers will identify which patients benefit most based on traits measured during initial sleep studies.See study design
What are the potential side effects?
Potential side effects from Atomoxetine and Oxybutynin may include allergic reactions like angioedema or urticaria, mood changes including mania or depression in young adults under 24 years old, constipation, difficulty urinating due to urinary retention, seizures in those predisposed to them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recent results from a sleep study done under sedation.
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I have or might have sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days 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
Secondary outcome measures
Arousal Index
Hypoxia

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
Group I: AtoOxy Predicted RespondersExperimental Treatment2 Interventions
Participants will take Atomoxetine (80mg) and Oxybutynin (5mg) before bedtime for 3 nights. Half doses will be given on the first night.
Group II: AtoOxy Predicted NonrespondersExperimental Treatment2 Interventions
Participants will take Atomoxetine (80mg) and Oxybutynin (5mg) before bedtime for 3 nights. Half doses will be given on the first night.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atomoxetine
2010
Completed Phase 4
~431790
Oxybutynin
2015
Completed Phase 4
~2720

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,604 Previous Clinical Trials
11,466,915 Total Patients Enrolled
Scott A Sands, PhDPrincipal InvestigatorBrigham and Women's Hospital
6 Previous Clinical Trials
243 Total Patients Enrolled

Media Library

Atomoxetine-plus-oxybutynin therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05550246 — Phase 1 & 2
Obstructive Sleep Apnea Research Study Groups: AtoOxy Predicted Responders, AtoOxy Predicted Nonresponders
Obstructive Sleep Apnea Clinical Trial 2023: Atomoxetine-plus-oxybutynin therapy Highlights & Side Effects. Trial Name: NCT05550246 — Phase 1 & 2
Atomoxetine-plus-oxybutynin therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05550246 — Phase 1 & 2

Frequently Asked Questions

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

How can I get involved in this experiment?

"The requirements for this study are that the patient must be experiencing obstructive sleep apnea and be between 21 and 70 years old. In total, the researchers need 22 participants."

Answered by AI

Are octogenarians excluded from participating in this research?

"This particular study is only recruiting patients that are aged 21-70, while there are other 51 trials for minors and 252 trials targeting an elderly demographic."

Answered by AI

Are there any more slots open for this clinical trial?

"Data from clinicaltrials.gov indicates that this particular study is not currently recruiting patients for participation. Although the trial's original posting was on October 1st 2023, the most recent update to the listing was on September 19th 2022. There are however, 311 other trials actively seeking participants."

Answered by AI
~6 spots leftby Dec 2024