Recruiting
Phase 1
Phase 2

Atomoxetine & DAW2022

Sponsor:

Brigham and Women's Hospital

Code:

NCT05350215

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Placebo oral capsule

Atomoxetine Oral Capsule [Strattera]

Study Details

Brief 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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT05350215

Start date

Jun 1, 2022

Status verified date

Jul, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Placebo oral capsule

Placebo pills for a week, 1 pill 4 hr before sleep and 1 pill 30 min before sleep

Atomoxetine 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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ludovico Messineo, MD, PhD

18572726188lmessineo@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02135

Contacts

Nicole Calianese

617-732-8976ncalianese@partners.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-10.