NCT03832244|Completed
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Sponsor study identifier
observational
199
1 country
1
Study Start
April 22, 2019
Actual (reported)Primary Completion
April 20, 2020
Actual (reported)Study Completion
January 24, 2021
Actual (reported)The investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific subjective scales.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 24, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2019
Actual (reported)February 6, 2019
Actual (reported)April 22, 2019
Actual (reported)April 20, 2020
Actual (reported)January 24, 2021
Actual (reported)Tongue base thickness
The closest distance between tongue base and the skin in the sagittal plane
Baseline
Retropalatal distance
The diameter of retropalatal space in the transverse dimension
Baseline
Distance between lingual arteries
Distance between lingual arteries in the transverse plane
Baseline
Stop-Bang questionnaire
Baseline
Berlin Questionnaire
Baseline
Pittsburgh Sleep Quality Index (PSQI)
Baseline
Neck circumference
Baseline
The thyromental distance
Baseline
Patients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography
Patients undergoing to Sub-mental ultrasonography with Mild sleep apnea: 5 to 14 events per hour measured in over-night polysomnography
Patients undergoing to Sub-mental ultrasonography with Moderate sleep apnea: 15 to 29 events per hour measured in over-night polysomnography
Patients undergoing to Sub-mental ultrasonography with Severe sleep apnea: 30 or more events per hour measured in over-night polysomnography
Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
* For study group: Patients who have been diagnosed as having obstructive sleep apnea on polysomnography * For control group: Patients who have a negative polysomnography or normal scores from subjective scales
Bartin State Hospital
Istanbul, Turkey (Türkiye)
Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
Ozge Yagcioglu Yassa, M.D.
Coordinator of Sleep Disorders Centre of Bartin State Hospital
199 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2019
First Posted
February 6, 2019
Study Start
April 22, 2019
Actual (reported)Evaluation of Prolidase in Obstructive Sleep Apnea Syndrome
Contact the study team to confirm eligibility.
Primary Completion
April 20, 2020
Actual (reported)Study Completion
January 24, 2021
Actual (reported)Last Updated
January 26, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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