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

Summary

The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested:

Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance.

Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.

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.

Sponsors & Collaborators

• Monash University

  collaborator OTHER

• American Heart Association

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Heart Foundation of Australia

  collaborator UNKNOWN

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Scott A Sands, PhD · Brigham and Women's Hospital

• Bradley A Edwards, PhD · Monash University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-06

Primary Completion

2023-05-01

Completion

2023-05-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States
• Australia

Study Locations