DAW1033B2 in Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) Clinical Trial

— OsaStimB2  

Official title:

Effect of DAW1033B2 on Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426631
• Other study ID #: 2014p001033B2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 15, 2017
• Est. completion date: January 20, 2020

Study information

• Verified date: February 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 20, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criterion:

• OSA: 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Placebo oral capsule
Placebo capsule 30 minutes before sleep
• DAW1033B2 oral capsule
DAW1033B2 capsule 30 minutes before sleep

Locations

Country	Name	City	State
United States	Sleep Disorders Research Program Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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