DAW2020 capsule for obstructive sleep apnea and its sleep-related traits
Tests DAW2020 taken before sleep in people with obstructive sleep apnea.
Key facts
- Who runs it
- Brigham and Women's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Registry title
- DAW2020 on OSA Endotypic Traits
- Status
- Enrolling by invitation
- Phase
- Phase 1/2
- People taking part
- 20 people, planned
- Started
- 15 Nov 2020
- Expected to end
- 15 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Placebo oral capsule
- DAW2020 oral capsule
- Record updated
- 15 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe obstructive sleep apnea (breathing stops and starts during sleep). It tests DAW2020 or a placebo capsule taken before sleep.
- Age
- 21 Years to 70 Years
- Sex
- All sexes can join.
- Disease stage
- Moderate to severe obstructive sleep apnea, with AHI ≥ 15 events/hr (breathing pauses per hour of sleep).
- Earlier treatment
- People cannot join if they use medicines that stimulate or slow breathing (such as opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid), SNRIs/SSRIs, or medicines that lengthen the QTc interval.
Main reasons for not taking part
- Major organ disease, neuromuscular or major neurological disease, heart failure, or another unstable major illness
- Breathing or sleep disorders other than obstructive sleep apnea, such as periodic limb movements (arousal index > 10/hr), narcolepsy or parasomnias
- Allergy to the study drug (angioedema or urticaria) or any reason DAW2020 cannot be used
- Low potassium, low magnesium, or uncontrolled thyroid disease
- Severe claustrophobia
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Who cannot take part
- Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid)
- All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements
- 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)
- Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
- Use of medications that lengthen QTc interval
- Use of SNRIs/SSRIs
- Contraindications to DAW2020
- Severe claustrophobia
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 70 years old?
Where in United States
- Brigham and Women's HospitalBoston, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- PlaceboPlacebo, for comparison
Placebo capsule 4 hours before sleep
Treatment: Placebo oral capsule
- DAW2020Existing treatment, for comparison
DAW2020 capsule 4 hours before sleep
Treatment: DAW2020 oral capsule
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of DAW2020 on Endotypic Traits in OSA
- Plain-language title
- DAW2020 capsule for obstructive sleep apnea and its sleep-related traitsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT04538755, who can take part
- Record updated
- 15 July 2026