Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Victoria
-
Notting Hill, Victoria, Australia, 3168
- Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University
-
-
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed OSA or suspected OSA based on snoring
Exclusion Criteria:
- Severe co-morbidities (cardiovascular, renal, lung disease, neurological), including:
Congestive heart failure, Neurological conditions that may affect sleep or breathing (e.g. neuromuscular diseases e.g. myasthenia gravis; neurodegenerative diseases e.g. Alzheimer's/Parkinson's)
- Medications that will substantially affect respiration, including opioids, barbiturates, theophylline, doxapram, acetazolamide, pseudoephedrine
- Claustrophobia
- Insomnia and other non-respiratory sleep disorders
- Inability to sleep supine
- Contraindications to oral appliances, including insufficient teeth to support the device, periodontal problems inducing tooth mobility, active temporomandibular joint disorder
- Allergy to lidocaine or oxymetazoline HCl
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combo, Mad, Sham, Oxygen
Order of interventions: Combo, Mad, Sham, Oxygen
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Combo, Oxygen, Mad, Sham
Order of interventions: Combo, Oxygen, Mad, Sham
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Combo, Oxygen, Sham, MAD
Order of interventions: Combo, Oxygen, Sham, MAD
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Combo, Sham, Mad, Oxygen
Order of interventions: Combo, Sham, Mad, Oxygen
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Combo, Sham, Oxygen, MAD
Order of interventions: Combo, Sham, Oxygen, MAD
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: MAD, Combo, Oxygen, Sham
Order of interventions: MAD, Combo, Oxygen, Sham
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: MAD, Combo, Sham, Oxygen
Order of interventions: MAD, Combo, Sham, Oxygen
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: MAD, Oxygen, Combo, Sham
Order of interventions: MAD, Oxygen, Combo, Sham
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: MAD, Oxygen, Sham, Combo
Order of interventions: MAD, Oxygen, Sham, Combo
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: MAD, Sham, Combo, Oxygen
Order of interventions: MAD, Sham, Combo, Oxygen
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: MAD, Sham, Oxygen, Combo
Order of interventions: MAD, Sham, Oxygen, Combo
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Oxygen, Combo, Sham, MAD
Order of interventions: Oxygen, Combo, Sham, MAD
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Oxygen, MAD, Sham, Combo
Order of interventions: Oxygen, MAD, Sham, Combo
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Oxygen, Sham, Combo, MAD
Order of interventions: Oxygen, Sham, Combo, MAD
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Oxygen, Sham, MAD, Combo
Order of interventions: Oxygen, Sham, MAD, Combo
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Sham, Combo, MAD, Oxygen
Order of interventions: Sham, Combo, MAD, Oxygen
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Sham, MAD, Combo, Oxygen
Order of interventions: Sham, MAD, Combo, Oxygen
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Sham, MAD, Oxygen, Combo
Order of interventions: Sham, MAD, Oxygen, Combo
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Sham, Oxygen, Combo, MAD
Order of interventions: Sham, Oxygen, Combo, MAD
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
|
Experimental: Sham, Oxygen, MAD, Combo
Order of interventions: Sham, Oxygen, MAD, Combo
|
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 Names:
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Names:
Both treatments will be administered simultaneously.
Other Names:
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in apnea hypopnea index (AHI), percent of baseline.
Time Frame: Single night
|
Primary test is difference between combination therapy and oral appliance
|
Single night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in frequency of arousals, percent of baseline.
Time Frame: Single night
|
Primary test is difference between combination therapy and oral appliance
|
Single night
|
|
Morning minus evening systolic blood pressure
Time Frame: Single night
|
Primary test is difference between combination therapy and oral appliance
|
Single night
|
|
Morning minus evening diastolic blood pressure
Time Frame: Single night
|
Primary test is difference between combination therapy and oral appliance
|
Single night
|
|
Patient reported sleep quality (visual analog scale)
Time Frame: Single night
|
Primary test is difference between combination therapy and oral appliance
|
Single night
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott A Sands, PhD, Brigham and Women's Hospital
- Principal Investigator: Bradley A Edwards, PhD, Monash University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P001037
- 15SDG25890059 (Other Grant/Funding Number: American Heart Association)
- R01HL128658 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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