- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538755
DAW2020 on OSA Endotypic Traits (SedOSA)
July 5, 2023 updated by: David Andrew Wellman, Brigham and Women's Hospital
Effect of DAW2020 on Endotypic Traits in OSA
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Two overnight sleep studies will be performed: a drug night and a placebo night.
The patient will breath spontaneously (without CPAP) for both nights.
On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnigraphy for monitoring sleep, physiological variables (endotypes), and respiratory events.
A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women.
DAW2020 34 mg will be given 4 hours before lights out.
Subjects will sleep at least 50% of the night in the supine position.
At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate.
After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Exclusion Criteria:
- All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
- Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- Use of SNRIs/SSRIs.
- 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)
- Contraindications to DAW2020
- Use of medications that lengthen QTc interval
- Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
- Severe claustrophobia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo capsule 4 hours before sleep
|
Placebo before sleep
|
Active Comparator: DAW2020
DAW2020 capsule 4 hours before sleep
|
DAW2020 34 mg 4 h before sleep, single night administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of DAW2020 on arousal threshold (%eupnea)
Time Frame: 1 night
|
Arousal threshold will be calculated using diaphragm EMG
|
1 night
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2020
Primary Completion (Estimated)
May 15, 2024
Study Completion (Estimated)
June 15, 2024
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (Actual)
September 4, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 5, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020p002760-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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