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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Ultrasound; Diagnostic Imaging
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bartin State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue base thickness	The closest distance between tongue base and the skin in the sagittal plane	Baseline
Retropalatal distance	The diameter of retropalatal space in the transverse dimension	Baseline
Distance between lingual arteries	Distance between lingual arteries in the transverse plane	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bartin State Hospital
• Investigators: Principal Investigator: Ozge Yagcioglu Yassa, M.D., Coordinator of Sleep Disorders Centre of Bartin State Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): January 24, 2021

Study Registration Dates

• First Submitted: February 3, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; sub-mental ultrasonography
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: BartinUyku

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No