Mandibular Positioning Techniques for Obstructive Sleep Apnea

Overseen By Enoch Ng, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two techniques to improve sleep for people with obstructive sleep apnea, a condition where breathing stops and starts during sleep. Researchers compare a speech positioning technique and an anterior protrusive technique, both designed to position the jaw to keep airways open. People diagnosed with obstructive sleep apnea and who have a prescription for a dental sleep appliance are a good fit for this trial. As an unphased trial, it offers participants the chance to explore innovative techniques that could enhance sleep quality.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these mandibular positioning techniques are safe for obstructive sleep apnea?

Research has shown that devices used to adjust jaw position, like those in this study, are generally safe. However, some individuals might experience jaw pain or discomfort. While specific information on side effects for the speech positioning technique is limited, similar methods for sleep apnea are considered safe.

The technique that moves the jaw forward might also cause similar jaw discomfort, but these side effects are usually mild and manageable. These treatments serve as alternatives for individuals who cannot use other options, such as CPAP machines, which some find uncomfortable. It is important to consult a doctor with any questions or concerns about trying these techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the speech positioning technique for obstructive sleep apnea because it offers a non-invasive alternative to traditional treatments like CPAP machines or dental devices. Unlike these standard methods, which require wearing devices during sleep, the speech positioning technique focuses on exercises that strengthen and position the muscles involved in breathing. This could potentially improve sleep quality without the need for bulky equipment. Additionally, it empowers patients by enabling them to take an active role in managing their condition through simple exercises.

What evidence suggests that these mandibular positioning techniques are effective for obstructive sleep apnea?

Research has shown that certain speech positioning techniques, which participants in this trial may receive, can help reduce pauses in breathing for people with obstructive sleep apnea. One study found that incorporating these techniques into positional therapy reduced breathing interruptions during sleep by 54%. Another study demonstrated that these techniques also improved oxygen levels. This evidence suggests that speech positioning could be a promising way to manage sleep apnea symptoms. Meanwhile, another arm of this trial will evaluate the anterior protrusive positioning technique, which researchers are also studying for its potential benefits in managing sleep apnea. ^{1 6 7 8 9}

Who Is on the Research Team?

Enoch Ng, DDS

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with obstructive sleep apnea and are prescribed a dental sleep appliance. They should be following the American Academy of Dental Sleep Medicine's treatment guidelines.

Inclusion Criteria

I have been diagnosed with obstructive sleep apnea.

I have a prescription for a dental device to help with sleep.

My treatment follows AADSM guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mandibular positioning using either the anterior protrusive or speech positioning technique

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Speech positioning technique

Trial Overview The study is comparing two ways to position the jaw using dental appliances: one method uses speech positioning, while the other uses an anterior protrusive technique. It aims to see which is more effective for patients with sleep apnea.

How Is the Trial Designed?

Group I: Speech Position Experimental Treatment 1 Intervention

use of speech positioning technique

Group II: Anterior Protrusive Active Control 1 Intervention

use of anterior protrusive positioning technique

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a study of 100 patients with obstructive sleep apnea treated with a mandibular advancement device (MAD), 80 patients were found to have positional dependency, showing significant improvement in their apnea-hypopnea index (AHI) from 32.1 to 8.6 after treatment.

The success rate of MAD treatment was notably higher in position-dependent patients (57.5% achieving a significant reduction in AHI) compared to non-dependent patients (30.0%), indicating that understanding a patient's positional dependency can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of positional dependency on outcomes of treatment with a mandibular advancement device. Lee, CH., Jung, HJ., Lee, WH., et al.[2012]

A new prosthesis was developed for a 62-year-old edentulous patient to prevent obstructive sleep apnea by positioning the mandible and tongue to reduce airway obstruction during sleep.

The appliance combines mandibular advancement and a vacuum device to hold the tongue forward, providing a novel treatment option for patients who typically have limited solutions for sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnoea in edentulous patients--design of a combination appliance: a case study. Robertson, CJ.[2004]

Mandibular advancement devices (MAD) are effective alternatives to CPAP for treating sleep apnea, and the DISE-SAM protocol can help identify suitable candidates for MAD by measuring the necessary jaw advancement during drug-induced sleep endoscopy in 161 patients.

The study found no direct relationship between the severity of sleep apnea and the recommendation for MAD, but there was a weak positive correlation between the degree of jaw advancement needed and the severity of the condition, suggesting a personalized approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Mandibular Advancement Maneuvers during Sleep Endoscopy with a Titratable Positioner: DISE-SAM Protocol. Fernández-Sanjuán, P., Arrieta, JJ., Sanabria, J., et al.[2022]

In a study of 29 patients with moderate-to-severe Obstructive Sleep Apnea (OSA), the fully customizable Mandibular Advancement Device (IMYS) significantly reduced the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) after three months of use.

The IMYS device also improved oxygen saturation levels, indicating its potential effectiveness as a treatment option for patients with more severe forms of OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a modified mandibular advancement device for OSA treatment in a group of adult patients. Ciavarella, D., Campobasso, A., Cazzolla, AP., et al.[2023]

In a study of 14 men with obstructive sleep apnea, using a titratable oral appliance significantly reduced the apnea-hypopnea index, indicating improved sleep quality (P < .01).

The study found that changes in the upright position of the mandible were linked to significant increases in the size of the velopharynx and oropharynx when lying down, suggesting that the oral appliance's effectiveness may be due to its ability to enlarge these airway spaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interaction between changes in upright mandibular position and supine airway size in patients with obstructive sleep apnea. Tsuiki, S., Almeida, FR., Lowe, AA., et al.[2005]

The anterior mandibular positioning (AMP) device significantly reduced the apnea-hypopnea index (AHI) in patients with obstructive sleep apnea, showing a decrease from 35.6 to 22.7 after two weeks of use, and maintained a lower AHI of 25.3 after one year.

The device was well tolerated by 76% of patients over a year, with no long-term issues related to dental health or jaw function, although 29% discontinued use due to TMJ pain or unsatisfactory results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short and long-term usage of a dental device in sleep apnea syndrome. Peled, E., Yoffe, N., Blumenfeld, I., et al.[2009]

In a study of 15 patients with obstructive sleep apnea syndrome (OSAS), the Serenox anterior mandibular positioning device was successful in treating 87% of participants, significantly reducing the median apnoea/hypopnoea index from 36.25/h to 5.5/h after treatment.

While some mild side effects were reported, they were temporary and resolved after a few weeks, indicating that the device is generally well-tolerated and effective for conditions like snoring and mild OSAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anterior mandibular positioning device for the treatment of obstructive sleep apnoea syndrome: experience with the Serenox. Pellanda, A., Despland, PA., Pasche, P.[2019]

The adjustable mandibular positioning appliance significantly reduced the apnea/hypopnea index (AHI) from 44 to 12 events per hour, indicating its effectiveness in treating sleep apnea in 75 patients who completed follow-up polysomnography.

Patients reported a marked improvement in snoring severity, with only 2% of bedpartners noting loud snoring while using the appliance, and 86% of patients continued to use it nightly after an average of 350 days, showing good long-term adherence and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of variable mandibular advancement appliance for treatment of snoring and sleep apnea. Pancer, J., Al-Faifi, S., Al-Faifi, M., et al.[2019]

In a study of 15 patients with obstructive sleep apnea, the severity of temporomandibular disorders (TMD) remained mostly unchanged over a 24-month period of using mandibular advancement devices, indicating that long-term use may not worsen TMD symptoms.

However, patients who experienced temporomandibular joint crepitation were more likely to discontinue therapy, suggesting that this specific symptom could influence treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of mandibular advancement device therapy on the signs and symptoms of temporomandibular disorders. Näpänkangas, R., Raunio, A., Sipilä, K., et al.[2021]

The mandibular advancement prosthesis is an effective conservative treatment for obstructive sleep apnea, providing stability by engaging teeth on both dental arches.

A new technique allows for the fabrication of this prosthesis in one piece and in a single laboratory step, potentially reducing the time needed for its production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative technique for mandibular advancement prosthesis fabrication. Sadan, A., Novoselsky, A., Rogers, WA.[2019]

The study outlines a clinical and laboratory technique for creating a prosthesis aimed at preventing sleep apnea in patients without teeth (edentulous), focusing on maintaining a comfortable jaw position to keep the airway open during sleep.

Cephalograms are utilized during the prosthesis fabrication process to measure and ensure proper spatial alignment between the tongue and the pharyngeal wall, which is crucial for minimizing airway obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fabrication of a prosthesis to prevent sleep apnea in edentulous patients. Meyer, JB., Knudson, RC.[2019]

The adjustable thermoplastic mandibular advancement device (AT-MAD) significantly reduced the apnea-hypopnea index (AHI) from an average of 17.7 to 7.5, indicating effective treatment for obstructive sleep apnea (OSA) in 64 adult patients over a 4 to 6 month period.

Patients reported improved quality of life, with significant increases in Functional Outcomes of Sleep Questionnaire (FOSQ) scores, and 60.9% achieved an AHI of less than 5, demonstrating the device's efficacy, although some experienced mild adverse effects like TMJ discomfort and dry mouth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable thermoplastic mandibular advancement device for obstructive sleep apnea: outcomes and practicability. Banhiran, W., Kittiphumwong, P., Assanasen, P., et al.[2015]

Citations

1. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6622

Efficacy of the New Generation of Devices for Positional ... Combined data for studies reporting on the effect of PT show that there was a mean difference of 11.3 events/h (54% reduction) in apnea-hypopnea index and 33.6% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0278239124006827

Comparing Treatment Effectiveness and Patient-Reported ... Treatment options for OSA, include devices that assist breathing during sleep, intraoral devices that alter the positioning of the airway during sleep, and ...

3. aadsm.org aadsm.org/docs/jdsm.10.10.2024.o2.pdf

Comparing Anterior Protrusive and Speech-Positioned ... Abstract. Objective: This study aimed to determine the feasibility and potential efficacy of the speech positioning technique (SPT) versus ...

4. sleepmedres.org sleepmedres.org/journal/view.php?doi=10.17241/smr.2023.01837

Positional Therapy for Obstructive Sleep Apnea Positional therapy has shown promise in improving apneic events and lowest oxygen saturation in patients with position-dependent sleep apnea.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11830591/

a meta-analysis of mean changes in key outcomes - PMC Sleep positional therapy (SPT) showed a significant reduction in AHI in the supine position compared to placebo (MD = −7.46, 95% CI: −11.42, − ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05553860

Comparing Two Mandibular Positioning Techniques for ... This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning. Detailed Description.

7. withpower.com withpower.com/trial/phase-sleep-apnea-obstructive-11-2021-e5abb

Mandibular Positioning Techniques for Obstructive Sleep Apnea Mandibular positioning devices, used for treating sleep apnea, are generally safe but can cause side effects like jaw pain or discomfort in the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1087079224001333

Adverse events in patients with obstructive sleep apnea ... The odds of respiratory adverse events were significantly increased for patients with OSA (OR 1.65, 95 % CI 1.03–2.66, P = 0.04). Furthermore, the odds of ...

9. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202005-1939PP

Toward Rational Treatment for Obstructive Sleep Apnea The Neck Position Therapy Device (Night Shift; Advanced Brain Monitoring) showed a decrease in mean AHI from 24.7 events/h to 7.5 events/h (P < ...