Atomoxetine + Oxybutynin for Sleep Apnea

Overseen by Scott A Sands, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Scott A Sands, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I have recent results from a sleep study done under sedation.

I have or might have sleep apnea.

Exclusion Criteria

I have a sleep disorder like restless legs, sleep attacks, or unusual behaviors during sleep.

Pregnancy or nursing

I don't have allergies to atomoxetine or oxybutynin, heart, kidney, liver issues, or certain mental health conditions.

Treatment Details

Interventions

• Atomoxetine-plus-oxybutynin therapy (Other)

Trial Overview 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.

Participant Groups

Group I: AtoOxy Predicted Responders Experimental Treatment 2 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 Nonresponders Experimental Treatment 2 Interventions

Participants will take Atomoxetine (80mg) and Oxybutynin (5mg) before bedtime for 3 nights. Half doses will be given on the first night.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons