Mandibular Positioning Techniques for Obstructive Sleep Apnea

Recruiting in Palo Alto (17 mi)

Overseen by Enoch Ng, DDS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

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 data supports the effectiveness of the treatment Speech positioning technique for Obstructive Sleep Apnea?

Research on similar treatments, like the mandibular advancement device (MAD), shows they can help with obstructive sleep apnea by moving the lower jaw forward to keep the airway open. This suggests that techniques involving jaw positioning, like the Speech positioning technique, might also be effective. ^{1 2 3 4 5}

Is the mandibular positioning technique safe for humans?

Mandibular positioning devices, used for treating sleep apnea, are generally safe but can cause side effects like jaw pain or discomfort in the temporomandibular joint (the joint connecting the jawbone to the skull). Most patients tolerate these devices well, but some may experience persistent pain leading to discontinuation of use. ^{1 6 7 8 9}

How does the speech positioning technique treatment for obstructive sleep apnea differ from other treatments?

The speech positioning technique for obstructive sleep apnea is unique because it focuses on positioning the mandible (lower jaw) through speech exercises, which may offer a non-invasive alternative to devices like mandibular advancement prostheses that physically adjust jaw position. This approach could potentially improve airway patency (openness) during sleep without the need for dental devices. ^{1 2 10 11 12}

Research Team

Enoch Ng, DDS

Principal Investigator

University of Alberta

Eligibility Criteria

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 am 18 years old or older.

I have been diagnosed with obstructive sleep apnea.

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

Trial Timeline

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

Treatment Details

Interventions

• Speech positioning technique (Behavioural Intervention)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alberta Edmonton, Canada

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Findings from Research

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Short and long-term usage of a dental device in sleep apnea syndrome. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of positional dependency on outcomes of treatment with a mandibular advancement device. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of variable mandibular advancement appliance for treatment of snoring and sleep apnea. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The efficacy of a modified mandibular advancement device for OSA treatment in a group of adult patients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The interaction between changes in upright mandibular position and supine airway size in patients with obstructive sleep apnea. [2005]

6. England pubmed.ncbi.nlm.nih.gov

The anterior mandibular positioning device for the treatment of obstructive sleep apnoea syndrome: experience with the Serenox. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Adjustable thermoplastic mandibular advancement device for obstructive sleep apnea: outcomes and practicability. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing Mandibular Advancement Maneuvers during Sleep Endoscopy with a Titratable Positioner: DISE-SAM Protocol. [2022]

9. Lithuania pubmed.ncbi.nlm.nih.gov

Effect of mandibular advancement device therapy on the signs and symptoms of temporomandibular disorders. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

An alternative technique for mandibular advancement prosthesis fabrication. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Fabrication of a prosthesis to prevent sleep apnea in edentulous patients. [2019]

12. New Zealand pubmed.ncbi.nlm.nih.gov

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