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DAW2020 on OSA Endotypic Traits

NCT04538755 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-07

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

DRUG

Placebo oral capsule

Placebo before sleep

DRUG

DAW2020 oral capsule

DAW2020 34 mg 4 h before sleep, single night administration

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2024-05-15
Completion
2024-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538755 on ClinicalTrials.gov