Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03189173|
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : June 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Oral appliance Drug: Oxygen Other: Oral appliance plus oxygen Other: No treatment||Phase 2|
Pre-specified primary analysis for Aim 1 is the change in AHI with combination treatment versus oral appliance alone (%reduction versus placebo; including hypopnea events without desaturation/arousals).
Aim 2 seeks to identify subgroups of patients that have the greatest reduction in AHI (responders) with each treatment (post-hoc). We will use baseline physiological measures of the four traits causing OSA (collapsibility, responsiveness, loop gain, arousal threshold) to determine which characteristics predict responses to each intervention (leave-one-out support vector machine modeling). Clinical measures of the same traits will be estimated from the placebo night to confirm that responses can be predicted with clinically-available data. We will also test whether responders to oral appliances have a greater response to oxygen than oral appliance non-responders (and vice-versa), to address whether responders to both treatments are similar or different.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects will receive mandibular advancement, supplemental oxygen, mandibular advancement plus supplemental oxygen, and no treatment in randomized order. On nights without supplemental oxygen, subjects will be administered sham (air, single blinded). Oral appliance use will not be masked.|
|Masking:||None (Open Label)|
|Masking Description:||Supplemental oxygen versus air assignment nights will be blinded to participants, but will be known by the investigator. Oral appliances will be "open label".|
|Official Title:||Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea|
|Actual Study Start Date :||September 6, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: All patients
Patients will receive all four interventions in randomized order.
Note: Data will not be analyzed separately for the 16 cross-over combinations of intervention order:
Interventions: Oral appliance | Oral appliance plus oxygen | Oxygen | No treatment
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.
Other Name: Mandibular advancement device
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Name: Supplemental inspired oxygen
Other: Oral appliance plus oxygen
Both treatments will be administered simultaneously.
Other Name: Combination therapy
Other: No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Name: Sham
- Change in apnea hypopnea index (AHI), percent of baseline. [ Time Frame: Single night ]Primary test is difference between combination therapy and oral appliance
- Change in frequency of arousals, percent of baseline. [ Time Frame: Single night ]Primary test is difference between combination therapy and oral appliance
- Patient reported sleep quality (better/same/worse) [ Time Frame: Single night ]Primary test is difference between combination therapy and oral appliance
- Morning minus evening systolic blood pressure [ Time Frame: Single night ]Primary test is difference between combination therapy and oral appliance
- Morning minus evening diastolic blood pressure [ Time Frame: Single night ]Primary test is difference between combination therapy and oral appliance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189173
|Contact: Scott A Sands, PhDfirstname.lastname@example.org|
|Contact: Lauren Hessemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Scott A Sands, PhD 857-928-0341 firstname.lastname@example.org|
|Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University||Not yet recruiting|
|Notting Hill, Victoria, Australia, 3168|
|Contact: Bradley A Edwards, PhD 61 3 9905 0187 email@example.com|
|Principal Investigator:||Scott A Sands, PhD||Brigham and Women's Hospital|
|Principal Investigator:||Bradley A Edwards, PhD||Monash University|