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

NCT ID: NCT03832244

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-22

Study Completion Date

2021-01-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea Diagnostic Imaging Ultrasound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Simple snoring

Patients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography

Sub-mental ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Sub-mental ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Sub-mental ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Sub-mental ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sub-mental ultrasonography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bartin State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ozgeyagcioglu Yassa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ozge Yagcioglu Yassa, M.D.

Role: PRINCIPAL_INVESTIGATOR

Coordinator of Sleep Disorders Centre of Bartin State Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bartin State Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23675433 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BartinUyku

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.