Actively Recruiting

Phase 1
Phase 2
Age: 21Years - 70Years
All Genders
NCT05350215

Atomoxetine and DAW2022 on OSA Severity

Led by Brigham and Women's Hospital · Updated on 2026-03-03

18

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Atomoxetine and DAW2022 on OSA Severity

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate-to-severe obstructive sleep apnea with apnea-hypopnea index of 15 or more events per hour
  • Age between 21 and 70 years
Not Eligible

You will not qualify if you...

  • Presence of major organ system disease that prevents physiological measurements
  • Use of medications that stimulate or depress respiration, including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, or 4-hydroxybutanoic acid
  • Use of SNRIs or SSRIs
  • Neuromuscular disease or major neurological disorders
  • Heart failure or unstable major medical conditions
  • Sleep breathing disorders other than obstructive sleep apnea
  • Other sleep disorders such as periodic limb movements with arousal index over 10 per hour, narcolepsy, or parasomnias
  • Hypersensitivity to study drugs such as angioedema or urticaria
  • Contraindications to DAW2020
  • Use of medications that lengthen the QTc interval
  • Hypokalemia, hypomagnesemia, or uncontrolled thyroid disease
  • Severe claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02135

Actively Recruiting

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Research Team

L

Ludovico Messineo, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Atomoxetine and DAW2022 on OSA Severity | DecenTrialz