Effect of Atomoxetine and DAW2022 on OSA Severity
Brigham and Women's Hospital
Summary
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.
Description
Two overnight sleep studies will be performed: a drug night and a placebo night, with a month of washout between treatments. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnography for monitoring sleep, physiological variables (endotypes), and respiratory events. A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. The drugs will be administered as follows. The…
Eligibility
- Age range
- 21–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Moderate-to-severe OSA (AHI ≥ 15 events/hr) Exclusion Criteria: * 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 conditi…
Interventions
- DrugPlacebo oral capsule
Placebo pills for a week, 1 pill 4 hr before sleep and 1 pill 30 min before sleep
- DrugAtomoxetine Oral Capsule [Strattera]
Atomoxetine for a week: 40 mg for 3 days 30 min before sleep, 80 mg for 4 days 30 min before sleep Simultaneous administration of DAW2020 for a week, 34 mg 4 h before sleep
Location
- Brigham and Women's HospitalBoston, Massachusetts