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Aspects Associated With Sleep Quality

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ClinicalTrials.gov Identifier: NCT03766477
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Noéli Boscato, PhD, Federal University of Pelotas

Brief Summary:
Evaluate the correlation among the diagnostics of sleep bruxism and sleep quality obtained from the use of smartphone application (APP-Sleep Cycle®), PSG and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson).

Condition or disease Intervention/treatment
Sleep Bruxism Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson Diagnostic Test: Smartphone APP Diagnostic Test: Polysomnography

Detailed Description:
This study will evaluate the correlation between sleep bruxism and sleep quality diagnoses obtained using the application of the smartphone (APP-Sleep Cycle®), polysomnography and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson). Subjects (n = 40) between 19 and 60 years old will be submitted to polysomnography from January to December 2019. The questionnaires will be applied before the polysomnography, and the APP will be used together with the polysomnography. The data will be tabulated and a descriptive statistical analysis performed. Specific statistical tests will be determined after preliminary analysis of the data (α = 0.05).

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspects Associated With Bruxism and Sleep Quality
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2022

Group/Cohort Intervention/treatment
Individuals with sleep bruxism

Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality:

  • Pittsburgh Sleep Quality Index (IQSP) and Johansson
  • Smartphone APP
  • Polysomnography
Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson
All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.

Diagnostic Test: Smartphone APP
All study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.

Diagnostic Test: Polysomnography
All participants slept for one night in a sleep laboratory for PSG recording. The data will be confirmed by an otorhinolaryngology certified by the Brazilian Association of Sleep Disorders




Primary Outcome Measures :
  1. Data Collect on Sleep Quality with ISQP quastionario. [ Time Frame: 4 months after study start ]
    Sleep quality data will be collected from the ISQP quastionario

  2. Data Collect on Sleep Quality with the APP [ Time Frame: 4 months after study start ]
    The sleep quality data will be collected in the APP along with the polysomnography exam, and the efficiency of the sleep is measured (god >80% or bad <80%).

  3. Data Collect on Sleep Quality with polysomnography exam [ Time Frame: 4 months after study start ]
    The sleep quality data will be collected in the polysomnography exam along with the APP, and the efficiency of the sleep is measured (god >80% or bad <80%).



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All adults (aged 20 to 60 years) and elderly (aged > 60 years) who had undergone PSG at the Pelotas Sleep Institute (ISP), a private medical out patients clinic, from January to December 2019, will be invited to participate in the study.

Eligibility criteria includ adequate cognitive capacity to understand and answer the questionnaire. Written consent will be given by all participants who agreed to participate in the study.

Criteria

Inclusion Criteria:

  • Adults (aged 20 to 60 years) and elderly (aged > 60 years) (WHO-World Health Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766477


Contacts
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Contact: Noéli Boscato, PhD +55 53999530000 noeliboscato@gmail.com

Locations
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Brazil
Noéli Boscato Recruiting
Pelotas, Rio Grande Do Sul, Brazil, 96015560
Contact: Noéli Boscato, PhD         
Noéli Boscato Recruiting
Pelotas, RS, Brazil, 96015-560
Contact: Noéli Boscato, PhD    +5553999530000    noeliboscato@gmail.com   
Sponsors and Collaborators
Federal University of Pelotas
Investigators
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Principal Investigator: Noéli Boscato, PhD Federal University of Pelotas

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Responsible Party: Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT03766477     History of Changes
Other Study ID Numbers: FUPelotas2
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noéli Boscato, PhD, Federal University of Pelotas:
Sleep bruxism
Sleep
Sleep hygiene
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders