Sleep BruxismNCT06153810
Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
A study testing Biofeedback stimulation in people with Sleep Bruxism, run by Aesyra SA at 1 site in Italy.
Trial summary
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Bruxism
- What is being tested?
- Biofeedback stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 17 Nov 2023to 7 Nov 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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.
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- Suffering from periodontal disease.
- With occlusal or jaw abnormalities that prevent the wearing of a normal dental splint.
- Participants with pacemakers.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Irccs San Gerardo Dei Tintori
Monza, Monza E Brianza, 20900
About this study
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
- Conditions
- Sleep Bruxism
- Being tested
- Biofeedback stimulation
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback stimulationDevice
Delivery of the vibratory biofeedback stimulus
| Study group | Role | What they receive |
|---|---|---|
| Early stimulation | Experimental | Biofeedback treatment is started after two weeks of observation Receives: Device: Biofeedback stimulation |
| Delayed stimulation | Experimental | Biofeedback treatment is started after three weeks of observation Receives: Device: Biofeedback stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (8)
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).
Measured: 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).
Measured: 1 month
Relative change in average intensity of bruxism episodes
A measure of the average bite strength exerted during the bruxism episodes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start17 Nov 2023
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep BruxismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesyra SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcello Maddalone, Principal investigator, Fondazione IRCCS San Gerardo dei Tintori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153810
- Sponsor's protocol ID
- ABA020-CIP-001
- Status last verified
- Jan 2025
- First submitted
- 16 Nov 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
- ClinicalTrials.gov ID
- NCT06153810
- Acronym / sponsor ID
- ABA020-CIP-001
- Conditions
- Sleep Bruxism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aesyra SAIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 1 Dec 2023 (actual)
- 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.
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early stimulation | Experimental | Device: Biofeedback stimulationBiofeedback treatment is started after two weeks of observation |
| Delayed stimulation | Experimental | Device: Biofeedback stimulationBiofeedback treatment is started after three weeks of observation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Biofeedback stimulationDelivery of the vibratory biofeedback stimulus | Device | Delayed stimulation, Early stimulation |
Primary outcome
Reduction of the bruxism activity
Time frame: 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.
8 secondary outcomes
Reduction of the bruxism index
Time frame: 1 month
Reduction of the mean duration of sleep bruxism episode
Time frame: 1 month
Relative change in average intensity of bruxism episodes
Time frame: 1 month
Change in self-reported sleep quality marked on a visual analogue scale
Time frame: 1 month
Change in self-reported pain marked on a visual analogue scale
Time frame: 1 month
Change in self-reported comfort marked on a visual analogue scale
Time frame: 1 month
Change in self-reported retention marked on a visual analogue scale
Time frame: 1 month
Change in self-reported ease of breathing marked on a visual analogue scale
Time frame: 1 month
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 23 Dec 2025.
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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.
Marcello Maddalone principal investigator
Fondazione IRCCS San Gerardo dei Tintori
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback stimulation in people with Sleep Bruxism, run by Aesyra SA at 1 site in Italy.
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 10 inclusion and 9 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 23 Dec 2025. 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 Italy. 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?
Reduction of the bruxism activity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.