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

Completed

• Conditions: Ultrasound; Diagnostic Imaging; Obstructive Sleep Apnea
• Interventions: Diagnostic Test: Sub-mental ultrasonography

• Registration Number: NCT03832244
• Lead Sponsor: Bartin State Hospital

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.

Study Timeline

• Study First Submitted: 2019-02-03
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Study Start: 2019-04-22
• Primary Completion: 2020-04-20
• Status Verified: 2021-01
• Study Completion: 2021-01-24
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simple snoring	Sub-mental ultrasonography	Patients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography
Moderate OSA	Sub-mental ultrasonography	Patients undergoing to Sub-mental ultrasonography with Moderate sleep apnea: 15 to 29 events per hour measured in over-night polysomnography
Mild OSA	Sub-mental ultrasonography	Patients undergoing to Sub-mental ultrasonography with Mild sleep apnea: 5 to 14 events per hour measured in over-night polysomnography
Severe OSA	Sub-mental ultrasonography	Patients undergoing to Sub-mental ultrasonography with Severe sleep apnea: 30 or more events per hour measured in over-night polysomnography

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Neck circumference	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)
The thyromental distance	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
Berlin Questionnaire	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.
Pittsburgh Sleep Quality Index (PSQI)	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.
Stop-Bang questionnaire	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.

Trial Locations

Locations (1)

Bartin State Hospital; 🇹🇷 Istanbul, Turkey