DAW1033D in Obstructive Sleep Apnea

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2020-01-20

Brief Summary

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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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Detailed Description

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Conditions

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Obstructive Sleep Apnea (OSA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo capsule 30 minutes before sleep

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo before sleep

DAW1033D

DAW1033D capsule 30 minutes before sleep

Group Type ACTIVE_COMPARATOR

DAW1033D oral capsule

Intervention Type DRUG

DAW1033D before sleep

Interventions

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Placebo oral capsule

Placebo before sleep

Intervention Type DRUG

DAW1033D oral capsule

DAW1033D before sleep

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No