Bruxism, Sleep-RelatedNCT07453121
Smartwatch Analysis of Sleep Bruxism
An observational study of Bruxism, Sleep-Related, run by Cappadocia University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the differences in sleep stages and total sleep duration between individuals diagnosed with sleep bruxism and healthy controls. This will be achieved through the use of smartwatches, which offer advantages such as rapid data acquisition, easy accessibility, long-term monitoring… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Sleep-Related
- What is being tested?
- Smartwatch-based Sleep Monitoring
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of two distinct groups: individuals diagnosed with sleep bruxism and healthy controls, both aged between 18 and 50 years. Participants with sleep bruxism will be recruited from the Oral and Maxillofacial Clinic of Cappadocia University, who have received a definitive diagnosis of sleep bruxism. Healthy control participants, without a history of sleep bruxism or any other sleep disorder, will be recruited from the general community via [e.g., local advertisements, university staff/students, hospital staff]. Both groups will be selected based on specific inclusion and exclusion criteria to ensure homogeneity within groups and to facilitate a clear comparison of sleep stages and total sleep duration using smartwatch data.
Who may be able to join
- • Age 18-50 years.
- Complete natural dentition (excluding third molars).
- Willingness to wear a smartwatch for 7 consecutive nights.
Who cannot join
- • High risk of Obstructive Sleep Apnea (OSA): Candidates with a STOP-Bang questionnaire score ≥3 or Body Mass Index (BMI) >30 kg/m² were excluded. This was a critical step to ensure that any observed sleep fragmentation was not attributed to respiratory events [21].
- Systemic and Psychiatric Conditions: History of neurological disorders, psychiatric diagnosis, or systemic diseases (e.g., diabetes, hypertension, gastroesophageal reflux disease) that could alter sleep physiology.
- Medication Use: Current use of medications affecting the central nervous system or sleep architecture (e.g., antidepressants, sedatives, muscle relaxants).
- Lifestyle Factors: Excessive alcohol/caffeine consumption, shift work, or irregular sleep-wake schedules.
- Acute Pain: Presence of acute temporomandibular disorder (TMD) symptoms (e.g., painful restriction) to avoid pain-related sleep disturbances.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cappadocia University Faculty of Dentistry
Nevşehir, Nevşehir Province, 50040
About this study
Official title: Sleep Architecture Patterns in Individuals With Clinically Diagnosed Sleep Bruxism: A Pilot Smartwatch-Based Study
This study aims to investigate the differences in sleep stages and total sleep duration between individuals diagnosed with sleep bruxism and healthy controls. This will be achieved through the use of smartwatches, which offer advantages such as rapid data acquisition, easy accessibility, long-term monitoring capabilities, and the potential to engage a large number of participants.
It is anticipated that the findings of this study will serve as a pioneering effort in utilizing smartwatch applications for the continuous monitoring of sleep bruxism patients. Furthermore, it is expected to provide an alternative methodology for evaluating the impact of bruxism treatments on sleep quality, thereby contributing significantly to the existing literature. As smartwatches become more prevalent in health tracking, it is also envisioned that application developers will increasingly prioritize this area in their software development and updates
- Conditions
- Bruxism, Sleep-Related
- Being tested
- Smartwatch-based Sleep Monitoring
- Keywords
- bruxism, smartwatch, sleep bruxism
- Medical subject headings
- Sleep Bruxism, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch-based Sleep MonitoringOther
Participants will wear a smartwatch to collect sleep stage data and total sleep duration over a specified period.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Bruxism Group | This group will include participants diagnosed with sleep bruxism. Sleep stage data and total sleep duration will be collected using smartwatches. Receives: Other: Smartwatch-based Sleep Monitoring | |
| Healthy Control Group | This group will include healthy individuals with no diagnosis of sleep bruxism. Sleep stage data and total sleep duration will be collected using smartwatches. Receives: Other: Smartwatch-based Sleep Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Duration
Total time spent sleeping during the night as measured by a smartwatch (minutes). Results reported as the average total sleep duration over 7 consecutive nights.
Measured: Days 1-7 (average of 7 consecutive nights)
Secondary outcomes (1)
Sleep Stages Distribution
Percentage distribution of sleep stages (NREM1, NREM2, NREM3/Deep, REM) as measured by a smartwatch. Results reported as the average percentage for each stage over 7 consecutive nights.
Measured: Days 1-7 (average of 7 consecutive nights)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bruxism, Sleep-RelatedStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cappadocia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Gökçe Akbulut, Cappadocia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453121
- Sponsor's protocol ID
- Decision No:24.19 G. O
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kato T, Rompre P, Montplaisir JY, Sessle BJ, Lavigne GJ. Sleep bruxism: an oromotor activity secondary to micro-arousal. J Dent Res. 2001 Oct;80(10):1940-4. doi: 10.1177/00220345010800101501.
PubMed 11706956Akbulut K, Akbulut FG. Smartwatch-derived sleep estimates in individuals with probable sleep bruxism: an exploratory pilot study. BMC Oral Health. 2026 Jul 8. doi: 10.1186/s12903-026-09218-1. Online ahead of print.
PubMed 42420961
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Architecture Patterns in Individuals With Clinically Diagnosed Sleep Bruxism: A Pilot Smartwatch-Based Study
- ClinicalTrials.gov ID
- NCT07453121
- Acronym / sponsor ID
- Decision No:24.19 G. O
- Conditions
- Bruxism, Sleep-Related
- Keywords
- bruxism, smartwatch, sleep bruxism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cappadocia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 5 Mar 2026 (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.
This study aims to investigate the differences in sleep stages and total sleep duration between individuals diagnosed with sleep bruxism and healthy controls. This will be achieved through the use of smartwatches, which offer advantages such as rapid data acquisition, easy accessibility, long-term monitoring capabilities, and the potential to engage a large number of participants.
It is anticipated that the findings of this study will serve as a pioneering effort in utilizing smartwatch applications for the continuous monitoring of sleep bruxism patients. Furthermore, it is expected to provide an alternative methodology for evaluating the impact of bruxism treatments on sleep quality, thereby contributing significantly to the existing literature. As smartwatches become more prevalent in health tracking, it is also envisioned that application developers will increasingly prioritize this area in their software development and updates
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Bruxism Group | – | Other: Smartwatch-based Sleep MonitoringThis group will include participants diagnosed with sleep bruxism. Sleep stage data and total sleep duration will be collected using smartwatches. |
| Healthy Control Group | – | Other: Smartwatch-based Sleep MonitoringThis group will include healthy individuals with no diagnosis of sleep bruxism. Sleep stage data and total sleep duration will be collected using smartwatches. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of two distinct groups: individuals diagnosed with sleep bruxism and healthy controls, both aged between 18 and 50 years. Participants with sleep bruxism will be recruited from the Oral and Maxillofacial Clinic of Cappadocia University, who have received a definitive diagnosis of sleep bruxism. Healthy control participants, without a history of sleep bruxism or any other sleep disorder, will be recruited from the general community via [e.g., local advertisements, university staff/students, hospital staff]. Both groups will be selected based on specific inclusion and exclusion criteria to ensure homogeneity within groups and to facilitate a clear comparison of sleep stages and total sleep duration using smartwatch data.
Key inclusion criteria (3 listed)
- • Age 18-50 years.
Key exclusion criteria (5 listed)
- • High risk of Obstructive Sleep Apnea (OSA): Candidates with a STOP-Bang questionnaire score ≥3 or Body Mass Index (BMI) >30 kg/m² were excluded. This was a critical step to ensure that any observed sleep fragmentation was not attributed to respiratory events [21].
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 |
|---|---|---|
| Smartwatch-based Sleep MonitoringParticipants will wear a smartwatch to collect sleep stage data and total sleep duration over a specified period. | Other | Healthy Control Group, Sleep Bruxism Group |
Primary outcome
Total Sleep Duration
Time frame: Days 1-7 (average of 7 consecutive nights)
Total time spent sleeping during the night as measured by a smartwatch (minutes). Results reported as the average total sleep duration over 7 consecutive nights.
1 secondary outcome
Sleep Stages Distribution
Time frame: Days 1-7 (average of 7 consecutive nights)
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 9 Mar 2026.
- Results publication: PubMed 11706956Kato T, Rompre P, Montplaisir JY, Sessle BJ, Lavigne GJ. Sleep bruxism: an oromotor activity secondary to micro-arousal. J Dent Res. 2001 Oct;80(10):1940-4. doi: 10.1177/00220345010800101501.
- Derived from this study: PubMed 42420961Akbulut K, Akbulut FG. Smartwatch-derived sleep estimates in individuals with probable sleep bruxism: an exploratory pilot study. BMC Oral Health. 2026 Jul 8. doi: 10.1186/s12903-026-09218-1. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism, Sleep-Related, run by Cappadocia University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 9 Mar 2026. 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 Turkey (Türkiye). 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?
Total Sleep Duration (time frame: Days 1-7 (average of 7 consecutive nights)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07453121, which also lists 2 linked publications.
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 9 Mar 2026.