DAW2020 on OSA Endotypic Traits

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04538755
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo oral capsule — DRUG
    Placebo before sleep
  • DAW2020 oral capsule — DRUG
    DAW2020 34 mg 4 h before sleep, single night administration

Study Details

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.

Key Dates

First listed
Sep 4, 2020
Start date
Nov 15, 2020
Status verified
Jul 2026
Primary completion
May 15, 2025
Completion
Dec 15, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo capsule 4 hours before sleep
  • Active Comparator: DAW2020
    DAW2020 capsule 4 hours before sleep

Primary Outcome Measure

Effects of DAW2020 on arousal threshold (%eupnea) [ Time Frame: 1 night ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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