Atomoxetine and DAW2022 for Obstructive Sleep Apnea

This study is looking at how two medications, atomoxetine (Strattera) and DAW2022, might help people with obstructive sleep apnea (OSA). OSA is a common condition where breathing repeatedly stops and starts during sleep. Researchers want to see if combining atomoxetine and DAW2022 can reduce how severe your OSA is. You could be eligible if you are between 21 and 70 years old and have moderate-to-severe OSA (meaning you have at least 15 breathing pauses or shallow breaths per hour during sleep). The study will measure the effect of these drugs on your OSA severity after one week of treatment. The current recruitment status is unclear, and they plan to enroll 18 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves a drug night and a placebo night, with a month-long break between treatments.
What's involved
You would have two overnight sleep studies, where your sleep and breathing are monitored. Before each study night, you'll have a physical exam and, if you're a premenopausal woman, a pregnancy test. You will take atomoxetine for seven days (40 mg for 3 days, then 80 mg for 4 days) and DAW2022 for seven days (34 mg).
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at one week, after the drug and placebo treatments.

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NCT05350215

Atomoxetine and DAW2022 on OSA Severity

Recruiting
PHASE1Ages 21–70InterventionalTreatment
Brigham and Women's Hospital
~18 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Placebo oral capsuleAtomoxetine Oral Capsule [Strattera]

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of atomoxetine and DAW2020 on OSA severity
Measured over 1 week
Obstructive Sleep Apnea
1 sites across 1 states
Massachusetts1

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Eligibility criteria

Inclusion

Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Exclusion

All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
Use of SNRIs/SSRIs.
Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
Hypersensitivity to the study drug (angioedema or urticaria)
Contraindications to DAW2020
Use of medications that lengthen QTc interval
Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
Severe claustrophobia.
  • Effect of atomoxetine and DAW2020 on OSA severity1 week

    OSA severity will be quantified by the number of respiratory events/h (AHI)