Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Study Overview
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Brief Summary
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The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.

Official Title
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Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Conditions
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Sleep Bruxism

Intervention / Treatment
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* Device: Biofeedback stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 70 years, in good general health. Presence of at least one of the following: sleeping partner's report of tooth grinding sounds during sleep for at least three nights per week within the last 6 months, hypertrophy of the masseter muscle upon digital palpation. Presence of at least one of the following: signs of tooth attrition or shiny spots on dental restorations, self-report of masticatory muscle fatigue or pain at awakening. Previous prescription of a night splint for bruxism. Able to understand and follow the protocol and complete the self-administered paper questionnaires. Able to provide written informed consent to study participation and storage and processing of study data Exclusion Criteria: Allergic to Ethylene-Vinyl Acetate (EVA) copolymer. With more than two missing molars (excluding third molars). Ongoing orthodontic treatment (e.g. teeth alignment). With major neurological or psychiatric disorders including substance dependence. Using a removable dental prosthesis. Using a medication with known effects on sleep or motor behavior. Suffering from periodontal disease. With occlusal or jaw abnormalities that prevent the wearing of a normal dental splint. Participants with pacemakers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early stimulation<br>Biofeedback treatment is started after two weeks of observation | Device: Biofeedback stimulation<br>* Delivery of the vibratory biofeedback stimulus<br>|
| Experimental: Delayed stimulation<br>Biofeedback treatment is started after three weeks of observation | Device: Biofeedback stimulation<br>* Delivery of the vibratory biofeedback stimulus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the bruxism activity | Evaluation of the efficacy of AesyBite Active in reducing the bruxism activity expressed as total sleep bruxism duration per hour (TDPH, sec/hour) by at least 60% in the stimulation phase compared with baseline with a 10% non-inferiority margin. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the bruxism index | Evaluation of the efficacy of AesyBite Active in reducing the bruxism index expressed as number of sleep bruxism episodes per hour (episodes/hour). | 1 month | 
| Reduction of the mean duration of sleep bruxism episode | Evaluation of the efficacy of AesyBite Active in reducing the mean duration of sleep bruxism episodes (sec/episode). | 1 month | 
| Relative change in average intensity of bruxism episodes | A measure of the average bite strength exerted during the bruxism episodes. | 1 month | 
| Change in self-reported sleep quality marked on a visual analogue scale | Change in self-reported sleep quality assessed using a visual analogue scale (VAS) with a sleep quality scale from 0 to 10. | 1 month | 
| Change in self-reported pain marked on a visual analogue scale | Change in self-reported pain (facial pain, myofascial headache) assessed using a visual analogue scale (VAS) with a pain severity scale from 0 to 10. | 1 month | 
| Change in self-reported comfort marked on a visual analogue scale | Change in self-reported comfort assessed using a visual analogue scale (VAS) with a comfort severity scale from 0 to 10. | 1 month | 
| Change in self-reported retention marked on a visual analogue scale | Change in self-reported retention assessed using a visual analogue scale (VAS) with a retention severity scale from 0 to 10. | 1 month | 
| Change in self-reported ease of breathing marked on a visual analogue scale | Change in self-reported ease of breathing assessed using a visual analogue scale (VAS) with a ease of breathing severity scale from 0 to 10. | 1 month |