NCT03832244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

February 3, 2019

Last Update Submit

January 24, 2021

Conditions

Obstructive Sleep ApneaDiagnostic ImagingUltrasound

Keywords

sub-mental ultrasonographyobstructive sleep apnea

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Stop-Bang questionnaire

    Baseline

  • Berlin Questionnaire

    Baseline

  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline

  • Neck circumference

    Baseline

  • The thyromental distance

    Baseline

Study Arms (4)

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

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

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

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

Interventions

Sub-mental ultrasonographyDIAGNOSTIC_TEST

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

Mild OSAModerate OSASevere OSASimple snoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patient who consented for sub-mental ultrasound

You may not qualify if:

  • Any pharyngo laryngeal anatomic abnormality
  • Previous history of Obstructive sleep apnea treatment
  • Previous history of surgical intervention to the pharyngo laryngeal anatomic area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartin State Hospital

Istanbul, Turkey (Türkiye)

Location

Related 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.

    PMID: 23675433RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ozge Yagcioglu Yassa, M.D.

    Coordinator of Sleep Disorders Centre of Bartin State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2019

First Posted

February 6, 2019

Study Start

April 22, 2019

Primary Completion

April 20, 2020

Study Completion

January 24, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)