Sleep Apnea SyndromesOSA-MADNCT01005940

Dental Device for Treatment of Sleep Apnea

A study testing Mandibular advancement device in people with Sleep Apnea Syndromes, run by Ulysses Magalang MD at 1 site in United States.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Apnea Syndromes
What is being tested?: Mandibular advancement device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Dec 2014
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Apnea-hypopnea index (AHI) of at least 20 events/hr based on overnight polysomnography
> 18 years of age
Unable to tolerate or refuse CPAP treatment

Who cannot join

Known diabetes mellitus
Body mass index (BMI) > 45 kg/m2
Uncontrolled hypertension
Known congestive heart failure
Use of illicit drugs
Excessive alcohol consumption, defined as:

Show all 13Show fewer

More than 3 glasses of wine a day
More than 3 beers a day
More than 60 mL of hard liquor a day
Room air oxyhemoglobin saturation < 90%
Use of home oxygen
Use of corticosteroids
Unable to give voluntary consent

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices

This study is being done to see if treatment of obstructive sleep apnea (OSA) with a mandibular advancement device (MAD) shows an increase in the quality of life. Many patients prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of snoring and mild to moderate obstructive sleep apnea. The investigators will also see how helpful the mandibular advancement device is on insulin resistance.

Read the detailed description

Patients with obstructive sleep apnea (OSA) will be included in this prospective controlled trial. OSA patients who are unable to tolerate CPAP or refuse CPAP(Continuous positive airway pressure) (and who are deemed appropriate by their attending physician for dental device treatment of OSA will be randomized to a control group (no MAD treatment) or to active MAD therapy.

Epidemiologic studies suggest that OSA is associated with insulin resistance independent of other known risk factors such as obesity. The cyclic intermittent hypoxia in OSA is the primary stimulus that leads to insulin resistance, a primary risk factor for the development of type 2 diabetes. There is an association between the level of hypoxic stress in OSA and insulin resistance.

The overall hypothesis to be tested is that treatment of OSA with MAD will improve insulin sensitivity, increase levels of HMW (High-molecular- weight) adiponectin, and improve psychological adjustment.

Conditions: Sleep Apnea Syndromes
Being tested: Mandibular advancement device
Keywords: Sleep Apnea Syndromes, Insulin Resistance, Mandibular advancement device
Medical subject headings: Sleep Apnea Syndromes, Insulin Resistance

What participants receive

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

Mandibular advancement deviceDevice
Mandibular advancement device made to subject specific specifications

Study groups in NCT01005940
Study group	Role	What they receive
Mandibular advancement device	Experimental	Subject is evaluated when receiving intervention with mandibular advancement device. Receives: Device: Mandibular advancement device
No mandibular advancement device	No intervention	Subject is evaluated when not receiving treatment with mandibular advancement device.

What is being measured

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

Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity
Measured: 16 weeks

Secondary outcomes (2)

Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation
Measured: 16 weeks
Treatment of OSA with mandibular advancement device improves psychological adjustment.
Measured: 16 weeks

Timeline

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

Jan 2010Dec 2014

First posted2 Nov 2009 (estimated)
Study startJan 2010
Primary completionJun 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
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 N/A
Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01005940
Sponsor's protocol ID: 2009H0131
Acronym: OSA-MAD
Status last verified: Jul 2021
First submitted: 30 Oct 2009
Last updated: 30 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
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

All Sleep Apnea Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices
ClinicalTrials.gov ID: NCT01005940
Acronym / sponsor ID: OSA-MAD / 2009H0131
Conditions: Sleep Apnea Syndromes
Keywords: Sleep Apnea Syndromes, Insulin Resistance, Mandibular advancement device
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Ulysses Magalang MDUniversity, hospital or other
Study start: Jan 2010 (actual)
Primary completion: Jun 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 2 Nov 2009 (estimated)
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.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mandibular advancement device	Experimental	Device: Mandibular advancement deviceSubject is evaluated when receiving intervention with mandibular advancement device.
No mandibular advancement device	No intervention	–Subject is evaluated when not receiving treatment with mandibular advancement device.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Apnea-hypopnea index (AHI) of at least 20 events/hr based on overnight polysomnography
> 18 years of age
Unable to tolerate or refuse CPAP treatment

Key exclusion criteria (13 listed)

Known diabetes mellitus
Body mass index (BMI) > 45 kg/m2
Uncontrolled hypertension
Known congestive heart failure
Use of illicit drugs

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
Mandibular advancement deviceMandibular advancement device made to subject specific specifications	Device	Mandibular advancement device

Primary outcome

Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity
Time frame: 16 weeks

2 secondary outcomes

Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation
Time frame: 16 weeks
Treatment of OSA with mandibular advancement device improves psychological adjustment.
Time frame: 16 weeks

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 30 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Sleep Apnea Syndromes

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
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

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.

Ulysses Magalang, M.D. principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mandibular advancement device in people with Sleep Apnea Syndromes, run by Ulysses Magalang MD at 1 site in United States.

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 3 inclusion and 13 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

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?

Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity (time frame: 16 weeks). 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 NCT01005940.

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 30 Jul 2025.