What is atomoxetine and DAW2020 studying for obstructive sleep apnea?

Atomoxetine and DAW2020 are being studied to see how they affect the severity of obstructive sleep apnea, a condition that impacts breathing during sleep. Researchers want to understand if these drugs can improve sleep quality and breathing patterns. The study is sponsored by Brigham and Women's Hospital and aims to find better treatments for OSA.

Who may be eligible for this obstructive sleep apnea clinical trial?

Adults aged 21 to 70 years with moderate-to-severe obstructive sleep apnea may be eligible. Participants should not have major organ diseases, neurological disorders, or use certain medications that affect breathing. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this obstructive sleep apnea clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase 1

Phase 2

Age: 21Years - 70Years

All Genders

ID05350215

Effect of Atomoxetine and DAW2022 on Obstructive Sleep Apnea Severity

Led by Brigham and Women's Hospital · Updated on 2026-03-03

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research investigates the effects of atomoxetine combined with DAW2020 on the severity of obstructive sleep apnea OSA, a common condition with serious health impacts and limited treatment options. Previous studies showed that atomoxetine and oxybutynin could reduce OSA severity but also lowered the arousal threshold, which is important in OSA. DAW2020, a hypnotic that increased total sleep time in prior trials, may be a better option to pair with atomoxetine for this purpose. Participants will undergo two overnight sleep studies one with the study drugs and one with placebo, separated by a one-month washout period. Before each sleep study, they will have a physical exam and a pregnancy test if applicable. The drug regimen includes a 3-day run-in of atomoxetine 40 mg, then 80 mg for the following days, taken 30 minutes before sleep. DAW2020 34 mg will be given for one week, 4 hours before sleep. Sleep and respiratory variables will be monitored for at least four hours each night using full polysomnography. During the study, participants will be observed overnight in a sleep lab with detailed monitoring of sleep, breathing, and physiological variables. Researchers will measure the effect of the drugs on OSA severity, arousal index, and oxygen levels during sleep. The study uses a randomized, quadruple-blind design with placebo comparison. The total participation includes two sleep studies with a month apart, and safety and response will be closely assessed throughout.

CONDITIONS

Brief Title

Atomoxetine and DAW2022 on OSA Severity

Who Can Participate

Age: 21Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Moderate-to-severe obstructive sleep apnea with apnea-hypopnea index of 15 or more events per hour
Adults aged 21 to 70 years

You will not qualify if you...

Major organ system disease that prevents physiological measurements
Use of medications that stimulate or depress breathing, including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, or 4-hydroxybutanoic acid
Use of SNRIs or SSRIs
Neuromuscular disease or major neurological disorders
Heart failure or other unstable major medical conditions
Sleep disorders other than obstructive sleep apnea, including periodic limb movements, narcolepsy, or parasomnias
Hypersensitivity to study drugs such as angioedema or urticaria
Contraindications to DAW2020
Use of medications that lengthen QTc interval
Low potassium or magnesium levels, uncontrolled thyroid disease
Severe claustrophobia

Research Team

Ludovico Messineo, MD, PhD

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