The Effects of Oral Appliance Therapy on Masseter Muscle Activity in Obstructive Sleep Apnea

The Effects of Mandibular Advancement Appliance Therapy on Masseter Muscle Activity During Sleep in Obstructive Sleep Apnea Patients: a Study in Clinical Practice

Previous studies have shown that contractions of the jaw-closing masseter muscle (MAS) often occur shortly after respiratory events during sleep in obstructive sleep apnea (OSA) patients. Although it has been hypothesized that such non-specific motor activations may contribute to restoration of a compromised upper airway during respiratory events, proper physiological understanding of MAS contractions in patients with OSA is lacking. MAS contractions are usually associated with the termination of respiratory events, but these contractions do not always occur after respiratory events. Therefore, the above-stated hypothesis that "non-specific motor activations of the jaw-closing masseter muscle (MAS) may contribute to restoration of a compromised upper airway during respiratory events" is not accepted yet. Further, Kato et al. concluded from a recent study that MAS contraction is an orofacial manifestation of a general motor reaction to arousal occurring during sleep in OSA patients. This suggests that MAS contraction after a respiratory event is dependent on the arousal response rather than on the respiratory events per se.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: mandibular advancement appliance

Detailed Description

OSA patients will be invited for participation in this study when they fulfil the predetermined inclusion criteria and exclusion criteria. The number of OSA patients that will be included for this study will be 25 based on a power analysis with a power of 80% and a significance level of 5% (two-sided). Informed consent will be obtained by signing form approved by the ethics board of the Université de Montréal.

The patients will be instructed to wear the mandibular advancement appliance (MAA) every night upon delivery. After a habituation period of three to six months patients will undergo two follow-up polysomnographic (PSG) recordings (see below).

The study has a randomized controlled crossover design, in which two experimental conditions (with MAA in situ versus without MAA in situ) will be compared in random order. A washout period of one week will be used for the MAA therapy.The study consists of three PSG recordings per patient: a baseline recording for the inclusion/exclusion of patients, and two follow-up recordings. The first and second follow-up nights will be used to establish, in a random order, the baseline for masseter muscle activity and arousals, and the effects of the MAA on these parameters. The two follow-up recordings will be performed within one week.

The ambulatory follow-up PSG recordings will be obtained at home. The mounting will be performed by a trained sleep technician. PSG recordings are made using surface electrodes according to the standard technical protocol used in previous OSA studies at the same laboratory.

The PSG recordings will be scored manually in 30-s epochs, and standard sleep and respiratory outcome variables will be obtained. All data analyses will be performed under blind conditions for the PSG recordings (with or without an MAA in situ) by one technician.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1J4
      • Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age between 30-65 years
• OSA patients with an apnea-hypopnea index (AHI) between 15 and 45 events per hour, and a report of excessive daytime sleepiness (Epworth Sleepiness Score > 10) or at least two of the symptoms suggested by the American Academy of Sleep Medicine Task Force, e.g., unrefreshing sleep and daytime fatigue.

Exclusion Criteria:

• Evidence of respiratory/sleep disorders other than OSA
• a Body Mass Index (BMI) > 40, medication usage that could influence respiration or sleep
• reversible morphological upper airway abnormalities (e.g., enlarged tonsils)
• severe temporomandibular disorders
• untreated periodontal problems or dental pain
• a lack of retention possibilities for an MAA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mandibular advancement appliance; mandibular advancement appliance (SomnoDent by SomnoMed)	Device: mandibular advancement appliance; mandibular advancement appliance; Other Names: mandibular repositioning appliance; mandibular repositioning splint; mandibular advancement splint; oral appliance
No Intervention: without mandibular advancement appliance; no therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of masseter muscle activity events	Motor activations in the masseter muscle during sleep will be scored when the EMG level is at least 10% of the maximum voluntary contraction (MVC) established before sleep.	up to 6 month following start of use of mandibular advancement appliance

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rhythmic masticatory muscle activity index	Number of rhythmic masticatory muscle activity per hour of sleep	up to 6 month following start of use of mandibular advancement appliance

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: Academic Centre for Dentistry in Amsterdam

Publications and helpful links

General Publications

• Li D, Aarab G, Lobbezoo F, Arcache P, Lavigne GJ, Huynh N. The effects of mandibular advancement appliance therapy on the sequence of jaw-closing muscle activity and respiratory events in individuals with obstructive sleep apnea. Sleep Breath. 2022 Apr 28. doi: 10.1007/s11325-022-02624-z. Online ahead of print.
• Li D, Aarab G, Lobbezoo F, Arcache P, Lavigne GJ, Huynh N. Accuracy of sleep bruxism scoring based on electromyography traces of different jaw muscles in individuals with obstructive sleep apnea. J Clin Sleep Med. 2022 Jun 1;18(6):1609-1615. doi: 10.5664/jcsm.9940.
• Aarab G, Arcache P, Lavigne GJ, Lobbezoo F, Huynh N. The effects of mandibular advancement appliance therapy on jaw-closing muscle activity during sleep in patients with obstructive sleep apnea: a 3-6 months follow-up. J Clin Sleep Med. 2020 Sep 15;16(9):1545-1553. doi: 10.5664/jcsm.8612.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: randomized controlled trial; obstructive sleep apnea; therapy; oral appliance; mandibular advancement device; arousals; masseter muscle activity; mandibular advancement appliance
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 13-105-CERES-D; NH-13-SP-MassActivity (Other Identifier: Faculte de medecine dentaire, Universite de Montreal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED