DAW1033D in Obstructive Sleep Apnea

• Status: Completed
• Trial end date: 2020-01-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital

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