Atrial FibrillationNCT03835429
Effect of Oral Appliance Therapy on Atrial Fibrillation
A study testing MyTAP oral appliance plus mouth shield in people with Atrial Fibrillation, run by Texas A&M University at 1 site in United States.
Trial summary
This pilot study is expected to determine the efficacy of using the midline traction designed MyTAP plus mouth shield (MyTAP + MS) oral appliance combination in decreasing the number of Atrial Fibrillation events. The MS is a patient comfort accessory to the MyTAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- MyTAP oral appliance plus mouth shield
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 3 Jan 2025
- 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
- Pre-qualified for ablation AF intervention
- AF > 1 documented episode in a 24-hour electrocardiogram (ECG) Holter examination or implanted AF monitor in the previous 1 month prior to study enrollment; [AF episode defined as at least 12 hours duration]
- At least 8 teeth per arch to support OA device
- Use of continuous positive air pressure (CPAP)therapy and willingness to switch to OA use
- Willing and able to provide verbal and written informed consent
- Ability to understand how to apply and utilize the sleep recorder and the OA device
Who cannot join
- Patients with implantable cardiac rhythm device [pacemakers or internal cardiac device (ICDs)] or cardiopulmonary disease [heart failure, Chronic obstructive pulmonary disease (COPD), ventricular dysrhythmia]
- Unable or unwilling to complete the study demands and schedule
- Comorbidities of other sleep disorders other than OSA
- No active temporomandibular joint disorders (TMD) or jaw muscle pain, or morphological airway abnormalities
- Pre-existing difficulty swallowing; throat or neck related health issues; endocrine dysfunction; severe psychiatric and neurological disorders; intellectually disabled; handicaps limiting sleep position
- Previous OA therapy or restrictions in jaw opening
Show all 13Show fewer
- Prior ablation of AF, myocardial infarction (MI), stroke or decompensation of heart failure within the last six months, untreated overt hyper- or hypothyroidism
- Commencement of new anti-arrhythmic drug since last monitor check
- Pharmacological dependency
- Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol intake
- Mallampati score > III
- Palatine tonsils - grade > 2
- History of Uvulopalatopharyngoplasty (UPPP) surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M School of Dentistry, Health Science Center
Dallas, Texas, 75246
About this study
Official title: Oropharynx-Brainstem-Heart Connection: A Controlled Clinical Trial to Assess Atrial Fibrillation Attenuation in Patients Treated With Oral Appliance Therapy
This pilot study is expected to determine the efficacy of using the midline traction designed MyTAP plus mouth shield (MyTAP + MS) oral appliance combination in decreasing the number of Atrial Fibrillation events. The MS is a patient comfort accessory to the MyTAP.
Read the detailed description
Atrial fibrillation (AF) is highly prevalent in the U.S. and possesses a greater risk in patients with sleep disordered breathing (SDB) versus patients without SDB. AF recurrence after catheter ablation is associated with 25% increased risk in patients with obstructive sleep apnea (OSA). One hypothesis suggests that the repeated hypoxic episodes time-linked to OSA and central sleep apnea may act as chemo-reflex triggers that enhances brainstem sympathetic activity in conjunction with responses to OSA-event hypoxia. This hypothesis is believed to induce tachycardia and cardiovascular stress. In an animal model, episodes of hypoxia were shown to induce pulmonary vein burst firing and reduction of the negative tracheal pressure promptly restored normal sinus rhythm. The Trigemino-cardiac reflex hypothesis implicates chemo- and mechanoreceptors in the oronasal cavity that provides signaling to the reticular formation via the mesencephalic nucleus of the trigeminal nerve and serves to control breathing, cardiac function, blood pH (acidity), amongst other body functions.
The sympathetic system in patients with OSA syndrome is considered to be chronically hypersensitized. A hyperarousal state suggests AF patients with OSA would tend to have AF occur more frequently in conjunction with apnea hypopnea events. An increase in autonomic sympathetic cardiac dominance with a withdrawal of cardiac parasympathetic control could easily be driven by mechanoreceptors in the oropharynx upon airway narrowing and present as decreased heart rate variability. Considering that the upper airway is often the site of greatest airflow restriction (i.e. snoring), a potential sudden rise in autonomic sympathetic nerve activity in sensory afferent fibers from the oropharynx should be the first to communicate the airflow reduction to brainstem. This theory is supported by the investigators' preliminary data and those in other reports. Oral appliance (OA) therapy that prevents snoring in conjunction with a mouth shield should simultaneously facilitate an open airway and prevent mouth breathing. The combination effect is expected to decrease vagus nerve motor efferent activity to the esophagus, facilitate nasal breathing, reduce sympathetic tone, promote stable sleep and increase HRV(heart rate variability). In patients with AF, the MyTAP + MS intervention is likely to also facilitate putatively effective medical therapies, reduce noxious AF triggers, and maintain normal oral bacterial flora levels and cardiac functioning.
- Conditions
- Atrial Fibrillation
- Being tested
- MyTAP oral appliance plus mouth shield
- Keywords
- oral appliance, atrial fibrillation, sleep apnea, mouth shield, snoring
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyTAP oral appliance plus mouth shieldDevice
Also called Oral appliance midline traction
The midline traction oral appliance (MyTAP, Airway Management Inc.(AMI), Dallas Texas) is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared.
| Study group | Role | What they receive |
|---|---|---|
| MyTAP oral appliance plus mouth shield | Experimental | MyTAP plus mouth shield Receives: Device: MyTAP oral appliance plus mouth shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF incidence
Measured (%) incidence of paroxysmal AF episodes >10 seconds in duration, 1-month after starting OA (T1) therapy compared with 1-month prior to using OA.
Measured: 1 month
Periodontal conditions
Periodontal conditions (defined according to classification developed by Centers for Disease Control and Prevention and the American Academy of Periodontology (CDC-AAP)) 24 assessment at (T0) before MyTAP + MS initiation and after 1-month (T1).
Measured: 1 month
Secondary outcomes (5)
MyTAP advancement change from T1 to T2
OA advancement in mm
Measured: 1 month
Heart rate variability analysis after 1 month compared with baseline (T0)
HRV in ms
Measured: 1 month
Apnea hypopnea index after 1 month (T2) compared with T0-1
Number of apneas and hypopneas per hour of recording
Measured: 1 month
Oxygen desaturation index after 1 month (T2) compared with T0-1
Percent oxygen desaturation
Measured: 1 month
Epworth Sleepiness Scale (ESS); Score ≥10 is sleepy, ≥ 18 is very sleepy.
Change in subjective ESS score pre-OA intervention vs. after 4-weeks of OA use
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start15 Jan 2019
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Why it stopped: Recruitment difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized clinical controlled trial design
- Masking
- None (open label)
- Enrolment
- 3 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, TAMHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835429
- Sponsor's protocol ID
- IRB2018-0954
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharynx-Brainstem-Heart Connection: A Controlled Clinical Trial to Assess Atrial Fibrillation Attenuation in Patients Treated With Oral Appliance Therapy
- ClinicalTrials.gov ID
- NCT03835429
- Acronym / sponsor ID
- IRB2018-0954
- Conditions
- Atrial Fibrillation
- Keywords
- oral appliance, atrial fibrillation, sleep apnea, mouth shield, snoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 8 Feb 2019 (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.
This pilot study is expected to determine the efficacy of using the midline traction designed MyTAP plus mouth shield (MyTAP + MS) oral appliance combination in decreasing the number of Atrial Fibrillation events. The MS is a patient comfort accessory to the MyTAP.
Detailed description
Atrial fibrillation (AF) is highly prevalent in the U.S. and possesses a greater risk in patients with sleep disordered breathing (SDB) versus patients without SDB. AF recurrence after catheter ablation is associated with 25% increased risk in patients with obstructive sleep apnea (OSA). One hypothesis suggests that the repeated hypoxic episodes time-linked to OSA and central sleep apnea may act as chemo-reflex triggers that enhances brainstem sympathetic activity in conjunction with responses to OSA-event hypoxia. This hypothesis is believed to induce tachycardia and cardiovascular stress. In an animal model, episodes of hypoxia were shown to induce pulmonary vein burst firing and reduction of the negative tracheal pressure promptly restored normal sinus rhythm. The Trigemino-cardiac reflex hypothesis implicates chemo- and mechanoreceptors in the oronasal cavity that provides signaling to the reticular formation via the mesencephalic nucleus of the trigeminal nerve and serves to control breathing, cardiac function, blood pH (acidity), amongst other body functions.
The sympathetic system in patients with OSA syndrome is considered to be chronically hypersensitized. A hyperarousal state suggests AF patients with OSA would tend to have AF occur more frequently in conjunction with apnea hypopnea events. An increase in autonomic sympathetic cardiac dominance with a withdrawal of cardiac parasympathetic control could easily be driven by mechanoreceptors in the oropharynx upon airway narrowing and present as decreased heart rate variability. Considering that the upper airway is often the site of greatest airflow restriction (i.e. snoring), a potential sudden rise in autonomic sympathetic nerve activity in sensory afferent fibers from the oropharynx should be the first to communicate the airflow reduction to brainstem. This theory is supported by the investigators' preliminary data and those in other reports. Oral appliance (OA) therapy that prevents snoring in conjunction with a mouth shield should simultaneously facilitate an open airway and prevent mouth breathing. The combination effect is expected to decrease vagus nerve motor efferent activity to the esophagus, facilitate nasal breathing, reduce sympathetic tone, promote stable sleep and increase HRV(heart rate variability). In patients with AF, the MyTAP + MS intervention is likely to also facilitate putatively effective medical therapies, reduce noxious AF triggers, and maintain normal oral bacterial flora levels and cardiac functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized clinical controlled trial design
| Arm | Type | Receives |
|---|---|---|
| MyTAP oral appliance plus mouth shield | Experimental | Device: MyTAP oral appliance plus mouth shieldMyTAP plus mouth shield |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pre-qualified for ablation AF intervention
- AF > 1 documented episode in a 24-hour electrocardiogram (ECG) Holter examination or implanted AF monitor in the previous 1 month prior to study enrollment; [AF episode defined as at least 12 hours duration]
- At least 8 teeth per arch to support OA device
- Use of continuous positive air pressure (CPAP)therapy and willingness to switch to OA use
- Willing and able to provide verbal and written informed consent
Key exclusion criteria (13 listed)
- Patients with implantable cardiac rhythm device [pacemakers or internal cardiac device (ICDs)] or cardiopulmonary disease [heart failure, Chronic obstructive pulmonary disease (COPD), ventricular dysrhythmia]
- Unable or unwilling to complete the study demands and schedule
- Comorbidities of other sleep disorders other than OSA
- No active temporomandibular joint disorders (TMD) or jaw muscle pain, or morphological airway abnormalities
- Pre-existing difficulty swallowing; throat or neck related health issues; endocrine dysfunction; severe psychiatric and neurological disorders; intellectually disabled; handicaps limiting sleep position
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 |
|---|---|---|
| MyTAP oral appliance plus mouth shieldAlso: Oral appliance midline tractionThe midline traction oral appliance (MyTAP, Airway Management Inc.(AMI), Dallas Texas) is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared. | Device | MyTAP oral appliance plus mouth shield |
Primary outcome
AF incidence
Time frame: 1 month
Measured (%) incidence of paroxysmal AF episodes >10 seconds in duration, 1-month after starting OA (T1) therapy compared with 1-month prior to using OA.
Periodontal conditions
Time frame: 1 month
Periodontal conditions (defined according to classification developed by Centers for Disease Control and Prevention and the American Academy of Periodontology (CDC-AAP)) 24 assessment at (T0) before MyTAP + MS initiation and after 1-month (T1).
5 secondary outcomes
MyTAP advancement change from T1 to T2
Time frame: 1 month
Heart rate variability analysis after 1 month compared with baseline (T0)
Time frame: 1 month
Apnea hypopnea index after 1 month (T2) compared with T0-1
Time frame: 1 month
Oxygen desaturation index after 1 month (T2) compared with T0-1
Time frame: 1 month
Epworth Sleepiness Scale (ESS); Score ≥10 is sleepy, ≥ 18 is very sleepy.
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Recruitment difficulties.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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
TAMHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyTAP oral appliance plus mouth shield in people with Atrial Fibrillation, 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 6 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: stopped early, as of the sponsor's last update on 30 Sep 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 was stopped early (reason given: Recruitment difficulties.). Results are not available in the source record.
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?
AF incidence (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.