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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
mandibular advancement appliance
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, oral appliance, therapy, masseter muscle activity, randomized controlled trial, mandibular advancement device, mandibular advancement appliance, arousals

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mandibular advancement appliance

without mandibular advancement appliance

Arm Description

mandibular advancement appliance (SomnoDent by SomnoMed)

no therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

rhythmic masticatory muscle activity index
Number of rhythmic masticatory muscle activity per hour of sleep

Full Information

First Posted
December 4, 2013
Last Updated
May 10, 2018
Sponsor
Université de Montréal
Collaborators
Academic Centre for Dentistry in Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT02011425
Brief Title
The Effects of Oral Appliance Therapy on Masseter Muscle Activity in Obstructive Sleep Apnea
Official Title
The Effects of Mandibular Advancement Appliance Therapy on Masseter Muscle Activity During Sleep in Obstructive Sleep Apnea Patients: a Study in Clinical Practice
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Academic Centre for Dentistry in Amsterdam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, oral appliance, therapy, masseter muscle activity, randomized controlled trial, mandibular advancement device, mandibular advancement appliance, arousals

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mandibular advancement appliance
Arm Type
Experimental
Arm Description
mandibular advancement appliance (SomnoDent by SomnoMed)
Arm Title
without mandibular advancement appliance
Arm Type
No Intervention
Arm Description
no therapy
Intervention Type
Device
Intervention Name(s)
mandibular advancement appliance
Other Intervention Name(s)
mandibular advancement splint, oral appliance, mandibular repositioning splint, mandibular repositioning appliance
Intervention Description
mandibular advancement appliance
Primary Outcome Measure Information:
Title
number of masseter muscle activity events
Description
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.
Time Frame
up to 6 month following start of use of mandibular advancement appliance
Secondary Outcome Measure Information:
Title
rhythmic masticatory muscle activity index
Description
Number of rhythmic masticatory muscle activity per hour of sleep
Time Frame
up to 6 month following start of use of mandibular advancement appliance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly Huynh, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1J4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35484327
Citation
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.
Results Reference
derived
PubMed Identifier
35212262
Citation
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.
Results Reference
derived
PubMed Identifier
32501212
Citation
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.
Results Reference
derived

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

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