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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 belowSelect...
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
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 moreOther outcome measures
Arousal Threshold
Loop Gain
Tonic genioglossus activity, unadjusted for ventilatory drive (GGtonic,min)
+3 moreTrial 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
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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
1,622 Previous Clinical Trials
11,468,732 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled medical conditions.I am currently taking the medication being studied.I am currently taking SNRIs/SSRIs or anticholinergic medications.I have been diagnosed with severe sleep apnea or suspect I have it due to symptoms like snoring.Criterion: You cannot participate if you have specific health conditions, such as certain allergies, heart problems, or psychological issues.I do not have any major conditions like heart failure or severe neurological disorders.I have a lung condition that is not sleep-related and causes low oxygen levels.I have a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.I am not taking medications that affect my breathing.You haven't been using a CPAP machine for more than 1 week.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Atomoxetine-plus-Oxybutynin (AtoOxy)
- Group 3: Atomoxetine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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