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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early stimulation | Experimental | Biofeedback treatment is started after two weeks of observation |
|
| Delayed stimulation | Experimental | Biofeedback treatment is started after three weeks of observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback stimulation | Device | Delivery of the vibratory biofeedback stimulus |
|
| 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 |
| 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 |
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Inclusion Criteria:
Age 18 to 70 years, in good general health.
Presence of at least one of the following:
Presence of at least one of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Marcello Maddalone | Fondazione IRCCS San Gerardo dei Tintori | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Irccs San Gerardo Dei Tintori | Monza | Monza E Brianza | 20900 | Italy |
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| ID | Term |
|---|---|
| D020186 | Sleep Bruxism |
| ID | Term |
|---|---|
| D002012 | Bruxism |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020447 | Parasomnias |
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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 |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |