Atomoxetine and DAW2022 on OSA Severity

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05350215
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo oral capsule — DRUG
    Placebo pills for a week, 1 pill 4 hr before sleep and 1 pill 30 min before sleep
  • Atomoxetine Oral Capsule [Strattera] — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Mar 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo oral capsules
    Placebo (2 pills) before sleep for a week
  • Active Comparator: Atomoxetine and DAW2020 oral capsules
    DAW2020 34 mg 4 h before sleep, single night administration for a week. Simultaneous administration of atomoxetine 40 mg for 3 days 30 min before sleep, 80 mg for the following 4 days, 30 min before sleep

Primary Outcome Measure

Effect of atomoxetine and DAW2020 on OSA severity [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02135
Nicole Calianese
[email protected]
617-732-8976

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By research site
Brigham and Women's Hospital· Boston, MA

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