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The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales

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ClinicalTrials.gov Identifier: NCT03832244
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ozgeyagcioglu Yassa, Bartin State Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Diagnostic Imaging Ultrasound Diagnostic Test: Sub-mental ultrasonography

Detailed Description:

Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA). However, the availability of PSG is limited, particularly in developing and / or least developed countries. Sub-mental ultrasonography is stepped forward with its practical and cheap nature and its widespread use.

The investigators aimed to perform sub-mental ultrasonography to the patients who underwent to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA scales.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : May 23, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Simple snoring
Patients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography
Diagnostic Test: Sub-mental ultrasonography
Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries

Mild OSA
Patients undergoing to Sub-mental ultrasonography with Mild sleep apnea: 5 to 14 events per hour measured in over-night polysomnography
Diagnostic Test: Sub-mental ultrasonography
Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries

Moderate OSA
Patients undergoing to Sub-mental ultrasonography with Moderate sleep apnea: 15 to 29 events per hour measured in over-night polysomnography
Diagnostic Test: Sub-mental ultrasonography
Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries

Severe OSA
Patients undergoing to Sub-mental ultrasonography with Severe sleep apnea: 30 or more events per hour measured in over-night polysomnography
Diagnostic Test: Sub-mental ultrasonography
Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries




Primary Outcome Measures :
  1. Tongue base thickness [ Time Frame: Baseline ]
    The closest distance between tongue base and the skin in the sagittal plane

  2. Retropalatal distance [ Time Frame: Baseline ]
    The diameter of retropalatal space in the transverse dimension

  3. Distance between lingual arteries [ Time Frame: Baseline ]
    Distance between lingual arteries in the transverse plane


Secondary Outcome Measures :
  1. Stop-Bang questionnaire [ Time Frame: Baseline ]
    This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.

  2. Berlin Questionnaire [ Time Frame: Baseline ]

    The questionnaire consists of 3 categories related to the risk of having sleep apnea.

    Category 1 is positive if the total score is 2 or more points. Category 2 is positive if the total score is 2 or more points. Category 3 is positive if the answer to item 10 is 'Yes' or if the BMI of the patient is greater than 30kg/m2. (BMI is defined as weight (kg) divided by height (m) squared, i.e.., kg/m2). Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive. Total score is ranged between 0-3.


  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline ]
    The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  4. Neck circumference [ Time Frame: Baseline ]
    Neck circumference was measured with the head erect and eyes facing forward, horizontally at the upper margin of the thyroid cartilage (to the nearest 0.1 cm)

  5. The thyromental distance [ Time Frame: Baseline ]
    The thyromental distance is defined as the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended. It is measured with a ruler



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • 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
Criteria

Inclusion Criteria:

  • Patient who consented for sub-mental ultrasound

Exclusion Criteria:

  • Any pharyngo laryngeal anatomic abnormality
  • Previous history of Obstructive sleep apnea treatment
  • Previous history of surgical intervention to the pharyngo laryngeal anatomic area

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): NCT03832244


Contacts
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Contact: Ozge Yagcioglu Yassa, M.D. +905532668166 dr.ozgeyagcioglu@gmail.com
Contact: Murat Yassa, M.D. +905335106312 murat.yassa@gmail.com

Locations
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Turkey
Bartin State Hospital Recruiting
Istanbul, Turkey
Contact: Ozge Yagcioglu Yassa, M.D.    +905532668166    dr.ozgeyagcioglu@gmail.com   
Contact: Gokce Annac, M.D.    +905055152530    gokceakgunduz85@yahoo.com   
Principal Investigator: Ozge Yagcioglu Yassa, M.D.         
Sub-Investigator: Gokce Annac, M.D.         
Sub-Investigator: Murat Yassa, M.D.         
Sponsors and Collaborators
Bartin State Hospital
Investigators
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Principal Investigator: Ozge Yagcioglu Yassa, M.D. Coordinator of Sleep Disorders Centre of Bartin State Hospital

Publications of Results:
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Responsible Party: Ozgeyagcioglu Yassa, Principal Investigator, Bartin State Hospital
ClinicalTrials.gov Identifier: NCT03832244     History of Changes
Other Study ID Numbers: BartinUyku
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Ozgeyagcioglu Yassa, Bartin State Hospital:
sub-mental ultrasonography
obstructive sleep apnea

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases