DAW1033B2 in Obstructive Sleep Apnea (OsaStimB2)

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: Obstructive Sleep Apnea (OSA)

Treatments: Drug: Placebo oral capsule; Drug: DAW1033B2 oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03426631

2014p001033B2

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo before sleep

Treatment:

Drug: Placebo oral capsule

DAW1033B2 oral capsule

Experimental group

Description:

DAW1033B2 before sleep

Treatment:

Drug: DAW1033B2 oral capsule