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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832244
• Other study ID #: BartinUyku
• Status: Completed
• Start date: April 22, 2019
• Est. completion date: January 24, 2021

Study information

• Verified date: January 2021
• Source: Bartin State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 24, 2021
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Diagnostic Imaging
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Ultrasound

Intervention

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

Locations

Country	Name	City	State
Turkey	Bartin State Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bartin State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tongue base thickness	The closest distance between tongue base and the skin in the sagittal plane	Baseline
Primary	Retropalatal distance	The diameter of retropalatal space in the transverse dimension	Baseline
Primary	Distance between lingual arteries	Distance between lingual arteries in the transverse plane	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	Neck circumference	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)	Baseline
Secondary	The thyromental distance	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	Baseline