DAW1033B2 in Obstructive Sleep Apnea

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea (OSA)

In brief

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.

Key facts

Study ID

NCT03426631

Run by

Brigham and Women's Hospital

People needed

13

Starts

2017-09-15

Expected to finish

2020-01-20

Last updated by the study team

2020-02-19

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Sleep Disorders Research Program Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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