Sleep Architecture Patterns in Individuals With Clinically Diagnosed Sleep Bruxism: A Pilot Smartwatch-Based Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Total Sleep Duration
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Sleep Bruxism Group
This group will include participants diagnosed with sleep bruxism. Sleep stage data and total sleep duration will be collected using smartwatches.
Intervention: Smartwatch-based Sleep Monitoring (Other)
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.
Intervention: Smartwatch-based Sleep Monitoring (Other)
Outcomes
Primary Outcomes
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
- Sleep Stages Distribution(Days 1-7 (average of 7 consecutive nights))
Investigators
Funda Gökçe Akbulut
Assistant Professor
Cappadocia University