Aspects Associated With Sleep Quality
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03766477|
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment|
|Sleep Bruxism||Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson Diagnostic Test: Smartphone APP Diagnostic Test: Polysomnography|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
Individuals with sleep bruxism
Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality:
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
- 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
- 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%).
- 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%).
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
|Contact: Noéli Boscato, PhD||+55 email@example.com|
|Pelotas, Rio Grande Do Sul, Brazil, 96015560|
|Contact: Noéli Boscato, PhD|
|Pelotas, RS, Brazil, 96015-560|
|Contact: Noéli Boscato, PhD +5553999530000 firstname.lastname@example.org|
|Principal Investigator:||Noéli Boscato, PhD||Federal University of Pelotas|