NCT04538755 (SedOSA) is a Phase 1, PHASE2 clinical trial of DAW2020 oral capsule in Obstructive Sleep Apnea (OSA), sponsored by Brigham and Women's Hospital.

Who is sponsoring NCT04538755?

NCT04538755 is sponsored by Brigham and Women's Hospital.

What drugs are being tested in NCT04538755?

Interventions in NCT04538755: Placebo oral capsule, DAW2020 oral capsule.

What condition does NCT04538755 study?

NCT04538755 studies Obstructive Sleep Apnea (OSA).

Is NCT04538755 still recruiting?

NCT04538755 is currently status unknown. Last updated 7 July 2023.

Last reviewed 2023-07-07 · How we verify

NCT04538755: SedOSA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

DAW2020 on OSA Endotypic Traits

Status unknown Phase 1, PHASE2 Last updated 7 July 2023

What this trial tests

Phase 1, PHASE2 trial testing Placebo oral capsule in Obstructive Sleep Apnea (OSA) in 20 participants. Status unknown.

Timeline

15 November 2020

Primary endpoint
15 May 2024

15 June 2024

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	15 November 2020
Primary completion	15 May 2024
Estimated completion	15 June 2024
Sites	1 location across United States

Drugs / interventions tested

Placebo oral capsule
DAW2020 oral capsule — full drug profile →

Conditions studied

Obstructive Sleep Apnea (OSA) — all drugs for Obstructive Sleep Apnea (OSA) →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 21 to 70, any sex, with Obstructive Sleep Apnea (OSA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of Pimavanserin on the Respiratory Arousal Threshold from Sleep: A Randomized Trial.
Messineo L, Gell L, Calianese N, Sofer T, et al · · 2022 · cited 12× · PMID 35947827 · DOI 10.1513/annalsats.202205-419oc

Verify or expand the search:

Other recruiting trials for Obstructive Sleep Apnea (OSA)

Currently open trials in the same condition.

NCT07292922 — Digital-supported Orofacial Myofunctional Therapy in OSA · NA · recruiting
NCT06983769 — CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial · NA · recruiting
NCT07307560 — High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients · NA · recruiting
NCT07103941 — IOA Preventing Occlusal Changes With MAD Use · NA · recruiting
NCT07121452 — Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System · NA · recruiting

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04538755 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
Last refreshed: 7 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04538755.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing