Smartwatch Analysis of Sleep Bruxism

NCT07453121 | Completed

• 1 other identifier: Decision No:24.19 G. O
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

bruxism; smartwatch; sleep bruxism

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 1-7 (average of 7 consecutive nights)

Secondary Outcomes (1)

• Sleep Stages Distribution

  Days 1-7 (average of 7 consecutive nights)

Study Arms (2)

Sleep Bruxism Group

This group will include participants diagnosed with sleep bruxism. Sleep stage data and total sleep duration will be collected using smartwatches.

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.

Other: Smartwatch-based Sleep Monitoring

Interventions

Smartwatch-based Sleep Monitoring OTHER

Participants will wear a smartwatch to collect sleep stage data and total sleep duration over a specified period.

Healthy Control Group; Sleep Bruxism Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age 18-50 years.
• Complete natural dentition (excluding third molars).
• Willingness to wear a smartwatch for 7 consecutive nights.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cappadocia University: lead

Study Sites (1)

Cappadocia University Faculty of Dentistry

Nevşehir, Nevşehir Province, 50040, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 11706956 RESULT

MeSH Terms

Conditions

Sleep Bruxism; Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Habits; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 5, 2026
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)