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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03426631
Other study ID # 2014p001033B2
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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