Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

September 6, 2017

Primary Completion Date

May 1, 2023

Study Completion Date

May 1, 2023

Conditions
Obstructive Sleep Apnea
Interventions
DEVICE

Oral appliance

"An oral appliance (dental mouthpiece) will be used to improve upper airway patency. Patients who do not have their own custom dental oral appliance (various brands, commonly Herbst/Somnomed) will be provided with a device (BluePro, BlueSom) for the duration of the study.~Patients will also be administered sham (room air) at 4 L/min via nasal cannula."

DRUG

Oxygen

Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.

OTHER

Oral appliance plus oxygen

Both treatments will be administered simultaneously.

OTHER

No treatment

Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.

Trial Locations (2)

3168

Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University, Notting Hill

02115

Brigham and Women's Hospital, Boston

All Listed Sponsors
collaborator

Monash University

OTHER

collaborator

American Heart Association

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Heart Foundation of Australia

UNKNOWN

lead

Brigham and Women's Hospital

OTHER

NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea | Biotech Hunter | Biotech Hunter