DAW1033B2 in Obstructive Sleep Apnea

Phase 1

Completed

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Drug: DAW1033B2 oral capsule; Drug: Placebo oral capsule

• Registration Number: NCT03426631
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-08
• Primary Completion: 2019-10-01
• Study Completion: 2020-01-20
• Results First Submitted: 2020-01-24
• Results First Submitted QC: 2020-01-24
• Status Verified: 2020-02
• Results First Posted: 2020-02-07
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DAW1033B2 oral capsule	DAW1033B2 oral capsule	DAW1033B2 before sleep
Placebo	Placebo oral capsule	Placebo before sleep

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)	1 night	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)

Trial Locations

Locations (1)

Sleep Disorders Research Program Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States