NCT05350215 Atomoxetine and DAW2022 on OSA Severity
| NCT ID | NCT05350215 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2022-06-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05350215 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05350215 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05350215 currently recruiting?
Yes, NCT05350215 is actively recruiting participants. Contact the research team at lmessineo@bwh.harvard.edu for enrollment information.
Where is the NCT05350215 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05350215 clinical trial?
NCT05350215 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 18 participants.