An interventional study of Biofeedback stimulation in Sleep Bruxism, sponsored by Aesyra SA. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Aesyra SA · Not applicable, Interventional, and Treatment
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
60 studies on the registry are indexed under Sleep Bruxism; 10 are open to participants now.
This study's enrollment of 26 is below the median of 40 across 39 interventional studies indexed under Sleep Bruxism.
Browse Sleep Bruxism studies →This is the only study on the registry with Aesyra SA as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Presence of at least one of the following:
Presence of at least one of the following:
Exclusion Criteria:
Biofeedback treatment is started after two weeks of observation
Device: Biofeedback stimulation
Biofeedback treatment is started after three weeks of observation
Device: Biofeedback stimulation
Delivery of the vibratory biofeedback stimulus
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.
Time frame: 1 month
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).
Time frame: 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).
Time frame: 1 month
Relative change in average intensity of bruxism episodes
A measure of the average bite strength exerted during the bruxism episodes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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