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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 belowSelect...
I have moderate-to-severe sleep apnea.
SedOSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 night
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 night
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
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,618 Previous Clinical Trials
11,471,690 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have low potassium, low magnesium, or uncontrolled thyroid issues.I am not taking medications that affect my breathing.I have a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.I have no known allergies or adverse reactions to DAW2020.I am currently taking medication for depression or anxiety.I have a sleep or breathing disorder that is not obstructive sleep apnea.I am taking medication that affects my heart's electrical cycle.I do not have major neurological disorders, heart failure, or other unstable conditions.I have severe claustrophobia.I do not have any major organ disease that would prevent me from undergoing certain medical tests.I have moderate-to-severe sleep apnea.You have had a severe allergic reaction to the study drug, like swelling or hives.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: DAW2020
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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