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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03832244
Enrollment
199
Registered
2019-02-06
Start date
2019-04-22
Completion date
2021-01-24
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Imaging, Obstructive Sleep Apnea, Ultrasound

Keywords

sub-mental ultrasonography, obstructive sleep apnea

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.

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.

Interventions

DIAGNOSTIC_TESTSub-mental ultrasonography

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

Sponsors

Bartin State Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tongue base thicknessBaselineThe closest distance between tongue base and the skin in the sagittal plane
Retropalatal distanceBaselineThe diameter of retropalatal space in the transverse dimension
Distance between lingual arteriesBaselineDistance between lingual arteries in the transverse plane

Secondary

MeasureTime frameDescription
Neck circumferenceBaselineNeck 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)
Stop-Bang questionnaireBaselineThis 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.
The thyromental distanceBaselineThe 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
Berlin QuestionnaireBaselineThe 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.
Pittsburgh Sleep Quality Index (PSQI)BaselineThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026