Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
NCT ID: NCT03189173
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2017-09-06
2023-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Combo, Mad, Sham, Oxygen
Order of interventions: Combo, Mad, Sham, Oxygen
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Combo, Oxygen, Mad, Sham
Order of interventions: Combo, Oxygen, Mad, Sham
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Combo, Oxygen, Sham, MAD
Order of interventions: Combo, Oxygen, Sham, MAD
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Combo, Sham, Mad, Oxygen
Order of interventions: Combo, Sham, Mad, Oxygen
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Combo, Sham, Oxygen, MAD
Order of interventions: Combo, Sham, Oxygen, MAD
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
MAD, Combo, Oxygen, Sham
Order of interventions: MAD, Combo, Oxygen, Sham
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
MAD, Combo, Sham, Oxygen
Order of interventions: MAD, Combo, Sham, Oxygen
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
MAD, Oxygen, Combo, Sham
Order of interventions: MAD, Oxygen, Combo, Sham
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
MAD, Oxygen, Sham, Combo
Order of interventions: MAD, Oxygen, Sham, Combo
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
MAD, Sham, Combo, Oxygen
Order of interventions: MAD, Sham, Combo, Oxygen
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
MAD, Sham, Oxygen, Combo
Order of interventions: MAD, Sham, Oxygen, Combo
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Oxygen, Combo, Sham, MAD
Order of interventions: Oxygen, Combo, Sham, MAD
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Oxygen, MAD, Sham, Combo
Order of interventions: Oxygen, MAD, Sham, Combo
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Oxygen, Sham, Combo, MAD
Order of interventions: Oxygen, Sham, Combo, MAD
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Oxygen, Sham, MAD, Combo
Order of interventions: Oxygen, Sham, MAD, Combo
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Sham, Combo, MAD, Oxygen
Order of interventions: Sham, Combo, MAD, Oxygen
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Sham, MAD, Combo, Oxygen
Order of interventions: Sham, MAD, Combo, Oxygen
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Sham, MAD, Oxygen, Combo
Order of interventions: Sham, MAD, Oxygen, Combo
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Sham, Oxygen, Combo, MAD
Order of interventions: Sham, Oxygen, Combo, MAD
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Sham, Oxygen, MAD, Combo
Order of interventions: Sham, Oxygen, MAD, Combo
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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Interventions
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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.
Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygen
Both treatments will be administered simultaneously.
No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
21 Years
79 Years
ALL
No
Sponsors
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Monash University
OTHER
American Heart Association
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Heart Foundation of Australia
UNKNOWN
Brigham and Women's Hospital
OTHER
Responsible Party
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Scott Aaron Sands
Associate Physiologist / Instructor in Medicine
Principal Investigators
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Scott A Sands, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Bradley A Edwards, PhD
Role: PRINCIPAL_INVESTIGATOR
Monash University
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University
Notting Hill, Victoria, Australia
Countries
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References
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Hynes DJ, Mann DL, Landry SA, Joosten SA, Edwards BA, Hamilton GS. Night-to-night variability in obstructive sleep apnea severity, the physiological endotypes, and the frequency of flow limitation. Sleep. 2025 Apr 11;48(4):zsae295. doi: 10.1093/sleep/zsae295.
Other Identifiers
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15SDG25890059
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2017P001037
Identifier Type: -
Identifier Source: org_study_id
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