NCT04538755

DAW2020 on OSA Endotypic Traits

Effect of DAW2020 on Endotypic Traits in OSA

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of DAW2020 administered before sleep on OSA phenotype traits and OSA severity during sleep.

Detailed description

Two overnight sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnigraphy for monitoring sleep, physiological variables (endotypes), and respiratory events. A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. DAW2020 34 mg will be given 4 hours before lights out. Subjects will sleep at least 50% of the night in the supine position. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DRUG	Placebo oral capsule	Placebo before sleep
DRUG	DAW2020 oral capsule	DAW2020 34 mg 4 h before sleep, single night administration

Timeline

• Start date: 2020-11-15
• Primary completion: 2024-05-15
• Completion: 2024-06-15
• First posted: 2020-09-04
• Last updated: 2023-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study