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

NCT02011425 | Completed

• 2 other identifiers: 13-105-CERES-DNH-13-SP-MassActivity
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; oral appliance; therapy; masseter muscle activity; randomized controlled trial; mandibular advancement device; mandibular advancement appliance; arousals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• rhythmic masticatory muscle activity index

  up to 6 month following start of use of mandibular advancement appliance

Study Arms (2)

mandibular advancement appliance

EXPERIMENTAL

mandibular advancement appliance (SomnoDent by SomnoMed)

Device: mandibular advancement appliance

without mandibular advancement appliance

NO INTERVENTION

no therapy

Interventions

mandibular advancement appliance DEVICE

mandibular advancement appliance

Also known as: mandibular advancement splint, oral appliance, mandibular repositioning splint, mandibular repositioning appliance

mandibular advancement appliance

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead
• Academic Centre for Dentistry in Amsterdam: collaborator

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3T 1J4, Canada

Location

Related Publications (3)

• 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. 2023 May;27(2):757-764. doi: 10.1007/s11325-022-02624-z. Epub 2022 Apr 28.

  PMID: 35484327 DERIVED

• 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.

  PMID: 35212262 DERIVED

• 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.

  PMID: 32501212 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Nelly Huynh, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 13, 2013
• Study Start: February 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

CA (1)