Sleep Bruxism
Conditions
Brief summary
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
Interventions
DEVICEBiofeedback stimulation
Delivery of the vibratory biofeedback stimulus
Sponsors
Aesyra SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the bruxism activity | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the mean duration of sleep bruxism episode | 1 month | Evaluation of the efficacy of AesyBite Active in reducing the mean duration of sleep bruxism episodes (sec/episode). |
| Relative change in average intensity of bruxism episodes | 1 month | A measure of the average bite strength exerted during the bruxism episodes. |
| Change in self-reported sleep quality marked on a visual analogue scale | 1 month | Change in self-reported sleep quality assessed using a visual analogue scale (VAS) with a sleep quality scale from 0 to 10. |
| Reduction of the bruxism index | 1 month | Evaluation of the efficacy of AesyBite Active in reducing the bruxism index expressed as number of sleep bruxism episodes per hour (episodes/hour). |
| Change in self-reported comfort marked on a visual analogue scale | 1 month | Change in self-reported comfort assessed using a visual analogue scale (VAS) with a comfort severity scale from 0 to 10. |
| Change in self-reported retention marked on a visual analogue scale | 1 month | Change in self-reported retention assessed using a visual analogue scale (VAS) with a retention severity scale from 0 to 10. |
| Change in self-reported ease of breathing marked on a visual analogue scale | 1 month | 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. |
| Change in self-reported pain marked on a visual analogue scale | 1 month | 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. |
Countries
Italy
Outcome results
None listed