Trials / Completed
CompletedNCT03825237
Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism
Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism: a Case-control Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 116 (actual)
- Sponsor
- Federal University of Pelotas · Academic / Other
- Sex
- All
- Age
- 20 Years – 90 Years
- Healthy volunteers
- Accepted
Summary
This case-control study will evaluates the association between the definitive sleep bruxism diagnosis by gold-standard polysomnography examination obtained at Pelotas Sleep Institute and the sociodemographic, occupational, clinical conditions, sleep quality, sleep structure and Epworth sleepiness scale variables.
Detailed description
Currently, as sleep and awake bruxism are generally considered as different behaviours observed during sleep and wakefulness, respectively, the single definition for bruxism is recommended be "retired" in favour of 2 separate definitions. In this sense, the sleep bruxism is a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and is not a movement disorder or a sleep disorder in otherwise healthy individuals .The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires, clinical exams and portable devices, based on current knowledge, the polysomnography with audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism diagnosis. Included on the questionnaire there is a registration form, which contains: Sociodemographic: self-reported ethnicity, marital status, education level; Occupational: individuals were asked about work outside home, working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills. Sleep Quality, was evaluated with the following questions: Sleep behavioral, how long does it take to sleep; restless sleep; nightmares; heartburn, obstructive sleep apnea by polysomnography. Bedtime, sleep time. Waking during the night, insomnia. Morning wake up, headache on waking; Lastly, Sleep structure data: sleep onset latency, rapid eye movement, sleep latency, wake time after sleep onset, total sleep time, sleep efficiency, non-rapid eye movement, sleep time in stages N1, N2, and N3, REM sleep time, arousal, arousal per hour, respiratory disturbance index, apnea-hypopnea index; and Epworth Sleepiness Scale.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Polysomnography | The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism) |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2018-07-24
- Completion
- 2018-11-15
- First posted
- 2019-01-31
- Last updated
- 2019-07-08
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03825237. Inclusion in this directory is not an endorsement.