Atomoxetine and DAW2022 on OSA Severity

Description

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 Overview

Study Details

Study overview

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.

Effect of Atomoxetine and DAW2022 on OSA Severity

Atomoxetine and DAW2022 on OSA Severity

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Moderate-to-severe OSA (AHI ≥ 15 events/hr)
  • * 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.

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2024-06-01