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

B

Bartin State Hospital

Status

Completed

Conditions

Diagnostic Imaging
Obstructive Sleep Apnea
Ultrasound

Treatments

Diagnostic Test: Sub-mental ultrasonography

Study type

Observational

Funder types

Other

Identifiers

NCT03832244
BartinUyku

Details and patient eligibility

About

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.

Full 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.

Enrollment

199 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

199 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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