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OpenTrials
Completed

NCT Number: NCT07453121

Smartwatch Analysis of Sleep Bruxism

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cappadocia University Faculty of Dentistry

Nevşehir, Nevşehir Province, 50040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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.

Treatment and study plan

Smartwatch-based Sleep Monitoring

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sleep Stages Distribution

    Time frame: Days 1-7 (average of 7 consecutive nights)

    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.

Sponsors and collaborators

Lead sponsor

Cappadocia University

Other

Registry information

Official study title

Sleep Architecture Patterns in Individuals With Clinically Diagnosed Sleep Bruxism: A Pilot Smartwatch-Based Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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