Obstructive Sleep ApneaPhase 2NCT03189173

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

A Phase 2 study testing Oral appliance, Oxygen and Oral appliance plus oxygen in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 79 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Oral appliance, Oxygen and Oral appliance plus oxygen
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 2 sitesin 2 countries
Study dates: 6 Sep 2017to 1 May 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed OSA or suspected OSA based on snoring

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

Australia1 site

Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University
Notting Hill, Victoria, 3168

Other trials in Australia

About this study

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.

Read the 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.

Conditions: Obstructive Sleep Apnea
Being tested: Oral appliance, Oxygen, Oral appliance plus oxygen, No treatment
Keywords: Obstructive Sleep Apnea, Ventilatory Control Instability, Complex Sleep Apnea
Medical subject headings: Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral applianceDevice
Also called Mandibular advancement device
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.
OxygenDrug
Also called Supplemental inspired oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Oral appliance plus oxygenOther
Also called Combination therapy
Both treatments will be administered simultaneously.
No treatmentOther
Also called Sham
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.

Study groups in NCT03189173
Study group	Role	What they receive
Combo, Mad, Sham, Oxygen	Experimental	Order of interventions: Combo, Mad, Sham, Oxygen Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Combo, Oxygen, Mad, Sham	Experimental	Order of interventions: Combo, Oxygen, Mad, Sham Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Combo, Oxygen, Sham, MAD	Experimental	Order of interventions: Combo, Oxygen, Sham, MAD Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Combo, Sham, Mad, Oxygen	Experimental	Order of interventions: Combo, Sham, Mad, Oxygen Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Combo, Sham, Oxygen, MAD	Experimental	Order of interventions: Combo, Sham, Oxygen, MAD Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
MAD, Combo, Oxygen, Sham	Experimental	Order of interventions: MAD, Combo, Oxygen, Sham Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
MAD, Combo, Sham, Oxygen	Experimental	Order of interventions: MAD, Combo, Sham, Oxygen Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
MAD, Oxygen, Combo, Sham	Experimental	Order of interventions: MAD, Oxygen, Combo, Sham Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
MAD, Oxygen, Sham, Combo	Experimental	Order of interventions: MAD, Oxygen, Sham, Combo Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
MAD, Sham, Combo, Oxygen	Experimental	Order of interventions: MAD, Sham, Combo, Oxygen Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
MAD, Sham, Oxygen, Combo	Experimental	Order of interventions: MAD, Sham, Oxygen, Combo Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Oxygen, Combo, Sham, MAD	Experimental	Order of interventions: Oxygen, Combo, Sham, MAD Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Oxygen, MAD, Sham, Combo	Experimental	Order of interventions: Oxygen, MAD, Sham, Combo Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Oxygen, Sham, Combo, MAD	Experimental	Order of interventions: Oxygen, Sham, Combo, MAD Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Oxygen, Sham, MAD, Combo	Experimental	Order of interventions: Oxygen, Sham, MAD, Combo Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Sham, Combo, MAD, Oxygen	Experimental	Order of interventions: Sham, Combo, MAD, Oxygen Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Sham, MAD, Combo, Oxygen	Experimental	Order of interventions: Sham, MAD, Combo, Oxygen Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Sham, MAD, Oxygen, Combo	Experimental	Order of interventions: Sham, MAD, Oxygen, Combo Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Sham, Oxygen, Combo, MAD	Experimental	Order of interventions: Sham, Oxygen, Combo, MAD Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment
Sham, Oxygen, MAD, Combo	Experimental	Order of interventions: Sham, Oxygen, MAD, Combo Receives: Device: Oral appliance; Drug: Oxygen; Other: Oral appliance plus oxygen; Other: No treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in apnea hypopnea index (AHI), percent of baseline.
Primary test is difference between combination therapy and oral appliance
Measured: Single night

Secondary outcomes (4)

Change in frequency of arousals, percent of baseline.
Primary test is difference between combination therapy and oral appliance
Measured: Single night
Patient reported sleep quality (visual analog scale)
Primary test is difference between combination therapy and oral appliance
Measured: Single night
Morning minus evening systolic blood pressure
Primary test is difference between combination therapy and oral appliance
Measured: Single night
Morning minus evening diastolic blood pressure
Primary test is difference between combination therapy and oral appliance
Measured: Single night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 20171 May 2023

First posted16 Jun 2017
Study start6 Sep 2017
Primary completion1 May 2023
Study completion1 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03189173
Sponsor's protocol ID: 2017P001037
Other IDs: 15SDG25890059, R01HL128658
Status last verified: Apr 2025
First submitted: 14 Jun 2017
Last updated: 4 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: Deidentified subject data will be shared via an online repository.

Publications

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.
PubMed 39688178

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT03189173
Acronym / sponsor ID: 2017P001037
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea, Ventilatory Control Instability, Complex Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Monash University, American Heart Association, National Heart, Lung, and Blood Institute (NHLBI), Heart Foundation of Australia
Study start: 6 Sep 2017 (actual)
Primary completion: 1 May 2023 (actual)
Study completion: 1 May 2023 (actual)
First posted: 16 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 20
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.

Arm	Type	Receives
Combo, Mad, Sham, Oxygen	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Combo, Mad, Sham, Oxygen
Combo, Oxygen, Mad, Sham	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Combo, Oxygen, Mad, Sham
Combo, Oxygen, Sham, MAD	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Combo, Oxygen, Sham, MAD
Combo, Sham, Mad, Oxygen	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Combo, Sham, Mad, Oxygen
Combo, Sham, Oxygen, MAD	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Combo, Sham, Oxygen, MAD
MAD, Combo, Oxygen, Sham	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: MAD, Combo, Oxygen, Sham
MAD, Combo, Sham, Oxygen	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: MAD, Combo, Sham, Oxygen
MAD, Oxygen, Combo, Sham	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: MAD, Oxygen, Combo, Sham
MAD, Oxygen, Sham, Combo	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: MAD, Oxygen, Sham, Combo
MAD, Sham, Combo, Oxygen	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: MAD, Sham, Combo, Oxygen
MAD, Sham, Oxygen, Combo	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: MAD, Sham, Oxygen, Combo
Oxygen, Combo, Sham, MAD	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Oxygen, Combo, Sham, MAD
Oxygen, MAD, Sham, Combo	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Oxygen, MAD, Sham, Combo
Oxygen, Sham, Combo, MAD	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Oxygen, Sham, Combo, MAD
Oxygen, Sham, MAD, Combo	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Oxygen, Sham, MAD, Combo
Sham, Combo, MAD, Oxygen	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Sham, Combo, MAD, Oxygen
Sham, MAD, Combo, Oxygen	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Sham, MAD, Combo, Oxygen
Sham, MAD, Oxygen, Combo	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Sham, MAD, Oxygen, Combo
Sham, Oxygen, Combo, MAD	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Sham, Oxygen, Combo, MAD
Sham, Oxygen, MAD, Combo	Experimental	Device: Oral appliance, Drug: Oxygen, Other: Oral appliance plus oxygen, Other: No treatmentOrder of interventions: Sham, Oxygen, MAD, Combo

Who may qualify

Ages: 21 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosed OSA or suspected OSA based on snoring

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral applianceAlso: Mandibular advancement deviceAn 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.	Device	Combo, Mad, Sham, Oxygen, Combo, Oxygen, Mad, Sham, Combo, Oxygen, Sham, MAD, Combo, Sham, Mad, Oxygen, Combo, Sham, Oxygen, MAD, MAD, Combo, Oxygen, Sham, MAD, Combo, Sham, Oxygen, MAD, Oxygen, Combo, Sham, MAD, Oxygen, Sham, Combo, MAD, Sham, Combo, Oxygen, MAD, Sham, Oxygen, Combo, Oxygen, Combo, Sham, MAD, Oxygen, MAD, Sham, Combo, Oxygen, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Oxygen, Sham, MAD, Oxygen, Combo, Sham, Oxygen, Combo, MAD, Sham, Oxygen, MAD, Combo
OxygenAlso: Supplemental inspired oxygenSupplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.	Drug	Combo, Mad, Sham, Oxygen, Combo, Oxygen, Mad, Sham, Combo, Oxygen, Sham, MAD, Combo, Sham, Mad, Oxygen, Combo, Sham, Oxygen, MAD, MAD, Combo, Oxygen, Sham, MAD, Combo, Sham, Oxygen, MAD, Oxygen, Combo, Sham, MAD, Oxygen, Sham, Combo, MAD, Sham, Combo, Oxygen, MAD, Sham, Oxygen, Combo, Oxygen, Combo, Sham, MAD, Oxygen, MAD, Sham, Combo, Oxygen, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Oxygen, Sham, MAD, Oxygen, Combo, Sham, Oxygen, Combo, MAD, Sham, Oxygen, MAD, Combo
Oral appliance plus oxygenAlso: Combination therapyBoth treatments will be administered simultaneously.	Other	Combo, Mad, Sham, Oxygen, Combo, Oxygen, Mad, Sham, Combo, Oxygen, Sham, MAD, Combo, Sham, Mad, Oxygen, Combo, Sham, Oxygen, MAD, MAD, Combo, Oxygen, Sham, MAD, Combo, Sham, Oxygen, MAD, Oxygen, Combo, Sham, MAD, Oxygen, Sham, Combo, MAD, Sham, Combo, Oxygen, MAD, Sham, Oxygen, Combo, Oxygen, Combo, Sham, MAD, Oxygen, MAD, Sham, Combo, Oxygen, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Oxygen, Sham, MAD, Oxygen, Combo, Sham, Oxygen, Combo, MAD, Sham, Oxygen, MAD, Combo
No treatmentAlso: ShamSubjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.	Other	Combo, Mad, Sham, Oxygen, Combo, Oxygen, Mad, Sham, Combo, Oxygen, Sham, MAD, Combo, Sham, Mad, Oxygen, Combo, Sham, Oxygen, MAD, MAD, Combo, Oxygen, Sham, MAD, Combo, Sham, Oxygen, MAD, Oxygen, Combo, Sham, MAD, Oxygen, Sham, Combo, MAD, Sham, Combo, Oxygen, MAD, Sham, Oxygen, Combo, Oxygen, Combo, Sham, MAD, Oxygen, MAD, Sham, Combo, Oxygen, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Sham, Combo, MAD, Oxygen, Sham, MAD, Combo, Oxygen, Sham, MAD, Oxygen, Combo, Sham, Oxygen, Combo, MAD, Sham, Oxygen, MAD, Combo

Primary outcome

Change in apnea hypopnea index (AHI), percent of baseline.
Time frame: Single night
Primary test is difference between combination therapy and oral appliance

4 secondary outcomes

Change in frequency of arousals, percent of baseline.
Time frame: Single night
Patient reported sleep quality (visual analog scale)
Time frame: Single night
Morning minus evening systolic blood pressure
Time frame: Single night
Morning minus evening diastolic blood pressure
Time frame: Single night

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
Derived from this study: PubMed 39688178Hynes 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.
Individual participant dataSharing planned: Yes. Deidentified subject data will be shared via an online repository.

Related trials for Obstructive Sleep Apnea

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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott A Sands, PhD principal investigator

Brigham and Women's Hospital

Bradley A Edwards, PhD principal investigator

Monash University

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral appliance, Oxygen and Oral appliance plus oxygen in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in apnea hypopnea index (AHI), percent of baseline. (time frame: Single night). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03189173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.