Back to resultsDAW1033D in Obstructive Sleep Apnea (OSAstimD)
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo oral capsule
DAW1033D oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
Eligibility Criteria
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
Sites / Locations
- Sleep Disorders Research Program Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
DAW1033D
Arm Description
Placebo capsule 30 minutes before sleep
DAW1033D capsule 30 minutes before sleep
Outcomes
Primary Outcome Measures
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
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.
Secondary Outcome Measures
Collapsibility of the Upper Airway: VPassive
Ventilation when ventilatory drive is relatively low during sleep
Full Information
NCT ID
NCT03383887
First Posted
December 13, 2017
Last Updated
February 11, 2020
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03383887
Brief Title
DAW1033D in Obstructive Sleep Apnea
Acronym
OSAstimD
Official Title
Effect of DAW1033D on Obstructive Sleep Apnea and Its Phenotypic Traits
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule 30 minutes before sleep
Arm Title
DAW1033D
Arm Type
Active Comparator
Arm Description
DAW1033D capsule 30 minutes before sleep
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo before sleep
Intervention Type
Drug
Intervention Name(s)
DAW1033D oral capsule
Intervention Description
DAW1033D before sleep
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
Description
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.
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Collapsibility of the Upper Airway: VPassive
Description
Ventilation when ventilatory drive is relatively low during sleep
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sleep Disorders Research Program Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33491327
Citation
Taranto-Montemurro L, Sands S, Azarbarzin A, Calianese N, Vena D, Hess L, Kim SW, White DP, Wellman A. Impact of cold and flu medication on obstructive sleep apnoea and its underlying traits: A pilot randomized controlled trial. Respirology. 2021 May;26(5):485-492. doi: 10.1111/resp.14009. Epub 2021 Jan 24.
Results Reference
derived
Learn more about this trial
DAW1033D in Obstructive Sleep Apnea
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