DAW1033B2 in Obstructive Sleep Apnea (OsaStimB2)

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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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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