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OpenTrials
Completed

NCT Number: NCT03383887

DAW1033D in Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo oral capsule

Drug

Placebo before sleep

DAW1033D oral capsule

Drug

DAW1033D before sleep

Primary outcomes

  1. Apnea Hypopnea Index (AHI, Events/Hour of Sleep)

    Time frame: 1 night

    Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.

Secondary outcomes

  1. Collapsibility of the Upper Airway: VPassive

    Time frame: 1 night

    Ventilation when ventilatory drive is relatively low during sleep

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Effect of DAW1033D on Obstructive Sleep Apnea and Its Phenotypic Traits

Acronym: OSAstimD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2017
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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