Obstructive Sleep ApneaNCT03219034
Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality
A study testing oral appliance - A ; washout; oral appliance B and oral appliance - B; washout; oral appliance A in people with Obstructive Sleep Apnea, run by Texas A&M University at 1 site in United States.
Trial summary
This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- oral appliance - A ; washout; oral appliance B and oral appliance - B; washout; oral appliance A
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- OSA PSG or PG diagnosed adults within 1 year
- age >18
- Currently treated with continuous positive airway pressure (CPAP)
- AHI ≥ >30 events/hour of sleep
- Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint)
- BMI ≥ 30
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- At least 8 teeth per arch to support either OA device
- Central and mixed apnea index <5 events/hour
- Mallampati score from I to III
- Palatine tonsils - grade 0, 1, or 2
- Consent to study's timeline
- Willingness to wear home sleep test apparatus for at least 4 nights
- Willingness to wear an oral appliance every night for 8 weeks
- Willingness to pick up and return home sleep test kits as needed
Who cannot join
- Cardiac \& pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD);
- Central sleep apnea;
- Comorbidities with other sleep disorders
- No active TMD or jaw muscle pain
- Morphological airway abnormalities
- Pre-existing difficulty swallowing; throat or neck related health issues
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- Endocrine dysfunction
- Severe psychiatric disorders;
- Previous OA therapy; ENT surgery
- Restrictions in jaw opening
- Pregnancy / breast feeding or intent to become pregnant during the study
- Inability to apply the sleep recorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University College of Dentistry
Dallas, Texas, 75246
About this study
Official title: Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality
This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.
Read the detailed description
The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- oral appliance - A ; washout; oral appliance B, oral appliance - B; washout; oral appliance A
- Keywords
- oral appliance, sleep quality, sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral appliance - A ; washout; oral appliance BDevice
Also called "TAP1" Oral Appliance; washout; "SomnoDent Flex"
Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.
oral appliance - B; washout; oral appliance ADevice
Also called "SomnoDent Flex"; washout; "TAP1"
Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.
| Study group | Role | What they receive |
|---|---|---|
| Oral appliance - A | Experimental | Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.
Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX Receives: Device: oral appliance - A ; washout; oral appliance B; Device: oral appliance - B; washout; oral appliance A |
| Oral appliance - B | Experimental | Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.
Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX Receives: Device: oral appliance - A ; washout; oral appliance B; Device: oral appliance - B; washout; oral appliance A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Event Index (REI) at T2
Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing.
Measured: 4 weeks
Secondary outcomes (1)
Stable Sleep Percent
Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start10 Oct 2017
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emet D. Schneiderman, PhD, Texas A&M University
- Investigators
- Emet Schneiderman, PhD, Principal investigator, Texas A&M University College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219034
- Sponsor's protocol ID
- 2017-0390
- Status last verified
- Jan 2022
- First submitted
- 11 Jul 2017
- Last updated
- 10 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schneiderman E, Schramm P, Hui J, Wilson PD, Moura P, German Z, McCann A, Newton M. Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management. J Dent Res. 2021 Feb;100(2):155-162. doi: 10.1177/0022034520956977. Epub 2020 Sep 18.
PubMed 32942939
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality
- ClinicalTrials.gov ID
- NCT03219034
- Acronym / sponsor ID
- 2017-0390
- Conditions
- Obstructive Sleep Apnea
- Keywords
- oral appliance, sleep quality, sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Posted 10 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.
Detailed description
The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral appliance - A | Experimental | Device: oral appliance - A ; washout; oral appliance B, Device: oral appliance - B; washout; oral appliance AAnti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX |
| Oral appliance - B | Experimental | Device: oral appliance - A ; washout; oral appliance B, Device: oral appliance - B; washout; oral appliance AAnti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- OSA PSG or PG diagnosed adults within 1 year
- age >18
- Currently treated with continuous positive airway pressure (CPAP)
- AHI ≥ >30 events/hour of sleep
- Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint)
Key exclusion criteria (12 listed)
- Cardiac \& pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD);
- Central sleep apnea;
- Comorbidities with other sleep disorders
- No active TMD or jaw muscle pain
- Morphological airway abnormalities
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 appliance - A ; washout; oral appliance BAlso: "TAP1" Oral Appliance; washout; "SomnoDent Flex"Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. | Device | Oral appliance - A, Oral appliance - B |
| oral appliance - B; washout; oral appliance AAlso: "SomnoDent Flex"; washout; "TAP1"Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. | Device | Oral appliance - A, Oral appliance - B |
Primary outcome
Respiratory Event Index (REI) at T2
Time frame: 4 weeks
Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing.
1 secondary outcome
Stable Sleep Percent
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32942939Schneiderman E, Schramm P, Hui J, Wilson PD, Moura P, German Z, McCann A, Newton M. Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management. J Dent Res. 2021 Feb;100(2):155-162. doi: 10.1177/0022034520956977. Epub 2020 Sep 18.
- Individual participant dataSharing planned: No
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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.
Emet Schneiderman, PhD principal investigator
Texas A&M University College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral appliance - A ; washout; oral appliance B and oral appliance - B; washout; oral appliance A in people with Obstructive Sleep Apnea, run by Texas A&M University 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 14 inclusion and 12 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 10 Jan 2022. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Respiratory Event Index (REI) at T2 (time frame: 4 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 NCT03219034, 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 10 Jan 2022.