Atomoxetine and DAW2022 on OSA Severity
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21-70
SponsorBrigham and Women's Hospital
About this trial
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine.
Eligibility criteria
Qualifiers
Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Placebo oral capsule
- Atomoxetine Oral Capsule [Strattera]
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov