Obstructive Sleep ApneaNCT02011425
The Effects of Oral Appliance Therapy on Masseter Muscle Activity in Obstructive Sleep Apnea
A study testing mandibular advancement appliance in people with Obstructive Sleep Apnea, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- mandibular advancement appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- mandibular advancement appliance
- Keywords
- obstructive sleep apnea, oral appliance, therapy, masseter muscle activity, randomized controlled trial, mandibular advancement device, mandibular advancement appliance, arousals
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandibular advancement applianceDevice
Also called mandibular advancement splint, oral appliance, mandibular repositioning splint, mandibular repositioning appliance
mandibular advancement appliance
| Study group | Role | What they receive |
|---|---|---|
| mandibular advancement appliance | Experimental | mandibular advancement appliance (SomnoDent by SomnoMed) Receives: Device: mandibular advancement appliance |
| without mandibular advancement appliance | No intervention | no therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 month following start of use of mandibular advancement appliance
Secondary outcomes (1)
rhythmic masticatory muscle activity index
Number of rhythmic masticatory muscle activity per hour of sleep
Measured: up to 6 month following start of use of mandibular advancement appliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, Nelly Huynh, Université de Montréal
- Investigators
- Nelly Huynh, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011425
- Sponsor's protocol ID
- 13-105-CERES-D
- Other IDs
- NH-13-SP-MassActivity
- Status last verified
- May 2018
- First submitted
- 4 Dec 2013
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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. 2023 May;27(2):757-764. doi: 10.1007/s11325-022-02624-z. Epub 2022 Apr 28.
PubMed 35484327Li 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.
PubMed 35212262Aarab 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.
PubMed 32501212
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02011425
- Acronym / sponsor ID
- 13-105-CERES-D
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, oral appliance, therapy, masseter muscle activity, randomized controlled trial, mandibular advancement device, mandibular advancement appliance, arousals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mandibular advancement appliance | Experimental | Device: mandibular advancement appliancemandibular advancement appliance (SomnoDent by SomnoMed) |
| without mandibular advancement appliance | No intervention | –no therapy |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mandibular advancement applianceAlso: mandibular advancement splint, oral appliance, mandibular repositioning splint, mandibular repositioning appliancemandibular advancement appliance | Device | mandibular advancement appliance |
Primary outcome
number of masseter muscle activity events
Time frame: up to 6 month following start of use of mandibular advancement appliance
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.
1 secondary outcome
rhythmic masticatory muscle activity index
Time frame: up to 6 month following start of use of mandibular advancement appliance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 35484327Li 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.
- Derived from this study: PubMed 35212262Li 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.
- Derived from this study: PubMed 32501212Aarab 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly Huynh, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandibular advancement appliance in people with Obstructive Sleep Apnea, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of masseter muscle activity events (time frame: up to 6 month following start of use of mandibular advancement appliance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011425, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.