- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383887
DAW1033D in Obstructive Sleep Apnea (OSAstimD)
February 11, 2020 updated by: David Andrew Wellman, Brigham and Women's Hospital
Effect of DAW1033D on Obstructive Sleep Apnea and Its Phenotypic Traits
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited.
OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects.
In this protocol the investigators will test the effect of DAW1033D administered before sleep on OSA phenotype traits and OSA severity during sleep.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
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
- Sleep Disorders Research Program 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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- AHI > 15
Exclusion Criteria:
- Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia
- Any medication known to influence breathing, sleep/arousal or muscle physiology.
- Claustrophobia.
- Inability to sleep supine.
- Allergy to lidocaine, Oxymetazoline HCl, DAW1033D.
- Individuals with underlying cardiac disease, such as arrhythmias.
- Individuals taking psychiatric medications, or any of the studied medications for medical care.
- History of seizures
- For women: Pregnancy.
- History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
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 30 minutes before sleep
|
Placebo before sleep
|
Active Comparator: DAW1033D
DAW1033D capsule 30 minutes before sleep
|
DAW1033D before sleep
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
Time Frame: 1 night
|
Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility.
AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.
|
1 night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collapsibility of the Upper Airway: VPassive
Time Frame: 1 night
|
Ventilation when ventilatory drive is relatively low during sleep
|
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)
December 13, 2017
Primary Completion (Actual)
January 20, 2020
Study Completion (Actual)
January 20, 2020
Study Registration Dates
First Submitted
December 13, 2017
First Submitted That Met QC Criteria
December 26, 2017
First Posted (Actual)
December 27, 2017
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014p001033D
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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