Phase 2
N=11
DAW1033D in Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
Bottom Line
View on ClinicalTrials.gov: NCT03383887 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Apnea Hypopnea Index (AHI, Events/Hour of Sleep) — 21.6; 37.9 events/hour of sleep — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo oral capsule (Drug); DAW1033D oral capsule (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI, Events/Hour of Sleep) |
21.6; 37.9 | 0.56 |
| SECONDARY Collapsibility of the Upper Airway: VPassive |
74.8; 92.7 | 0.027 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03383887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.