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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
Suspected or diagnosed OSA
Be older than 18 years old
Must not have
Other sleep disorders: periodic limb movements, narcolepsy, or parasomnias
Contraindications for atomoxetine and oxybutynin, including: hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria), pheochromocytoma, use of monoamine oxidase inhibitors, benign prostatic hypertrophy, urinary retention, untreated narrow angle glaucoma, bipolar disorder, mania, psychosis, history of major depressive disorder (age<24), history of attempted suicide or suicidal ideation within one year prior to screening, clinically significant constipation, gastric retention, pre-existing seizure disorders, clinically-significant kidney disorders (eGFR<60 ml/min/1.73m2), clinically-significant liver disorders, clinically-significant cardiovascular conditions, moderate-to-severe hypertension (SBP>180 mmHg or DBP>110 mmHg measured at baseline; average of evening and morning measures*), cardiomyopathy (LVEF<50%) or heart failure, advanced atherosclerosis, history of cerebrovascular events, history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation, other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate, myasthenia gravis, Claustrophobia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights

Summary

This trial tests a combination of two medications, atomoxetine and oxybutynin, to reduce sleep apnea severity. Previous studies have shown that the combination of these medications can significantly reduce obstructive sleep apnea severity by increasing upper airway muscle activity during sleep. It focuses on patients with specific traits that might make them more likely to respond well to this treatment. The medications help keep the airway open by affecting muscle control and reducing collapsibility.

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.
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.
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 or might have sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a sleep disorder like restless legs, sleep attacks, or unusual behaviors during sleep.
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I don't have allergies to atomoxetine or oxybutynin, heart, kidney, liver issues, or certain mental health conditions.
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I am not taking medications that affect my breathing.
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I am currently taking SNRIs/SSRIs or anticholinergic medications.
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I do not have any uncontrolled medical conditions.
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I do not have major neurological disorders, heart failure, or other unstable conditions.
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I have a lung condition that is not sleep-related and causes low oxygen levels.
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I am currently taking sleep medications.
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I am currently taking the medication being studied.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apnea
Secondary study objectives
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
~2750

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Obstructive Sleep Apnea (OSA) include pharmacological agents like Atomoxetine and Oxybutynin. Atomoxetine, a selective norepinephrine reuptake inhibitor, increases norepinephrine levels, which can enhance upper airway muscle tone and reduce airway collapse during sleep. Oxybutynin, an anticholinergic agent, reduces muscle spasms and airway resistance through its antimuscarinic effects. These mechanisms are crucial for OSA patients as they offer a pharmacological means to reduce OSA severity by improving airway patency, providing an alternative or complement to traditional treatments like CPAP.
The norepinephrine reuptake inhibitor reboxetine alone reduces obstructive sleep apnea severity: a double blind, placebo controlled, randomized, cross-over trial.The pharmacotherapeutic management of obstructive sleep apnea.The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,655 Previous Clinical Trials
11,499,571 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
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