DAW1033B2 in Obstructive Sleep Apnea
OsaStimB2
Effect of DAW1033B2 on Obstructive Sleep Apnea
1 other identifier
interventional
13
1 country
1
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 DAW1033B2 administered before sleep on OSA phenotype traits and OSA severity during sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2017
CompletedFirst Submitted
Initial submission to the registry
February 2, 2018
CompletedFirst Posted
Study publicly available on registry
February 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2020
CompletedResults Posted
Study results publicly available
February 7, 2020
CompletedFebruary 19, 2020
February 1, 2020
2 years
February 2, 2018
January 24, 2020
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
Based on previous studies the investigators anticipate that DAW1032B2 will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI\<32), Vpassive \> 50% of Veupnea (ventilation during eupneic ventilatory drive)
1 night
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo before sleep
DAW1033B2 oral capsule
EXPERIMENTALDAW1033B2 before sleep
Interventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Luigi Taranto Montemurro, MD
- Organization
- Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor HMS
Study Record Dates
First Submitted
February 2, 2018
First Posted
February 8, 2018
Study Start
September 15, 2017
Primary Completion
October 1, 2019
Study Completion
January 20, 2020
Last Updated
February 19, 2020
Results First Posted
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share