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Completed

NCT Number: NCT03832244

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Diagnostic Imaging Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Ultrasound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bartin State Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sub-mental ultrasonography

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bartin State Hospital

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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