- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07453121
Smartwatch Analysis of Sleep Bruxism
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nevşehir Province
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Nevşehir, Nevşehir Province, Turkey (Türkiye), 50040
- Cappadocia University Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Sleep Bruxism Group
This group will include participants diagnosed with sleep bruxism.
Sleep stage data and total sleep duration will be collected using smartwatches.
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Participants will wear a smartwatch to collect sleep stage data and total sleep duration over a specified period.
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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.
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Participants will wear a smartwatch to collect sleep stage data and total sleep duration over a specified period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total Sleep Duration
Time Frame: Days 1-7 (average of 7 consecutive nights)
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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.
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Days 1-7 (average of 7 consecutive nights)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sleep Stages Distribution
Time Frame: Days 1-7 (average of 7 consecutive nights)
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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.
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Days 1-7 (average of 7 consecutive nights)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Decision No:24.19 G. O
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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