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

Bartin State Hospital199 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

199

Conditions

Obstructive Sleep Apnea Diagnostic Imaging Ultrasound

Interventions

Sub-mental ultrasonographyDIAGNOSTIC_TEST

Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bartin State Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Tongue base thickness

The closest distance between tongue base and the skin in the sagittal plane

Time frame: Baseline

Retropalatal distance

The diameter of retropalatal space in the transverse dimension

Time frame: Baseline

Distance between lingual arteries

Distance between lingual arteries in the transverse plane

Time frame: Baseline

Secondary Outcomes

Stop-Bang questionnaire

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.

Time frame: Baseline

Berlin Questionnaire

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.

Time frame: Baseline

Pittsburgh Sleep Quality Index (PSQI)

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.

Data from ClinicalTrials.gov

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