Status:
UNKNOWN
Atomoxetine and DAW2022 on OSA Severity
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
PHASE2
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 sev...
Detailed Description
Two overnight sleep studies will be performed: a drug night and a placebo night, with a month of washout between treatments. The patient will breath spontaneously (without CPAP) for both nights. On th...
Eligibility Criteria
Inclusion
- Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05350215
Start Date
June 1 2022
End Date
June 1 2024
Last Update
July 7 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02135