Clinical trial NCT03825237: Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism
Official title: Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Bruxism, Adult
Keywords: diagnostic
polysomnography
sleep architecture
sleep bruxism
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are in the adult and elderly age group and who seek or are referred to the Pelotas Sleep Institute for polysomnography in the period from January 2015 to December 2017 were assessed.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who were undergone to polysomnography (PSG) at the Pelotas Sleep Institute (PSI);
* Adequate cognitive capacity to understand and answer the questionnaire.

Exclusion Criteria:

• Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.

Primary outcomes:
measure: Sleep Bruxism
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Noéli Boscato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
citation: Lavigne GJ, Rompre PH, Montplaisir JY. Sleep bruxism: validity of clinical research diagnostic criteria in a controlled polysomnographic study. J Dent Res. 1996 Jan;75(1):546-52. doi: 10.1177/00220345960750010601.
citation: Casett E, Reus JC, Stuginski-Barbosa J, Porporatti AL, Carra MC, Peres MA, de Luca Canto G, Manfredini D. Validity of different tools to assess sleep bruxism: a meta-analysis. J Oral Rehabil. 2017 Sep;44(9):722-734. doi: 10.1111/joor.12520. Epub 2017 Jun 5.
citation: Palinkas M, De Luca Canto G, Rodrigues LA, Bataglion C, Siessere S, Semprini M, Regalo SC. Comparative Capabilities of Clinical Assessment, Diagnostic Criteria, and Polysomnography in Detecting Sleep Bruxism. J Clin Sleep Med. 2015 Nov 15;11(11):1319-25. doi: 10.5664/jcsm.5196.