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DAW2020 for Obstructive Sleep Apnea (SedOSA Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 night
Awards & highlights

SedOSA Trial Summary

This trial will see if a new drug can help people with sleep apnea to get better sleep and reduce the severity of their condition.

Who is the study for?
This trial is for adults with moderate-to-severe Obstructive Sleep Apnea (OSA), having at least 15 events per hour. It's not suitable for those with other sleep disorders, on certain medications affecting respiration or QTc interval, allergic to the study drug, major organ diseases, severe claustrophobia, or unstable medical conditions.Check my eligibility
What is being tested?
The trial tests if DAW2020 oral capsules taken before sleep can improve OSA by preventing premature awakenings during obstructive events. Participants will be randomly given either DAW2020 or a placebo capsule to compare effects on OSA severity and traits.See study design
What are the potential side effects?
Potential side effects of DAW2020 may include allergic reactions like angioedema or urticaria for those sensitive to the drug. Other risks might relate to interactions with medications that affect breathing or heart rhythm but specific side effects are not listed.

SedOSA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate-to-severe sleep apnea.

SedOSA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 night
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of DAW2020 on arousal threshold (%eupnea)

SedOSA Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DAW2020Active Control1 Intervention
DAW2020 capsule 4 hours before sleep
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule 4 hours before sleep

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,604 Previous Clinical Trials
11,466,916 Total Patients Enrolled

Media Library

DAW2020 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04538755 — Phase 1 & 2
Obstructive Sleep Apnea Research Study Groups: Placebo, DAW2020
Obstructive Sleep Apnea Clinical Trial 2023: DAW2020 Highlights & Side Effects. Trial Name: NCT04538755 — Phase 1 & 2
DAW2020 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04538755 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
DAW2020 on OSA Endotypic Traits
David Andrew Wellman 2020. "DAW2020 on OSA Endotypic Traits". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04538755.
~0 spots leftby May 2024
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