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Ultrasound Against Obstructive Sleep Apnea

NCT02788149 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-01-05

No results posted yet for this study

Summary

To investigate the accuracy of neck ultrasound in identifying and discriminating the severity of obstructive sleep apnea (OSA).

Primary objective: To test the hypothesis that ultrasound can be used as a reliable tool for identifying the anatomic characteristics and dynamic changes of pharyngeal airspace in patients with OSA.

Secondary objective: Investigate if ultrasound can be used to discriminate OSA severity.

The investigators will compare these results to the results from polysomnography study.

Conditions

Interventions

DEVICE

Ultrasound Exam

Ultrasound of Neck will be used to assess the Lateral parapharyngeal wall thickness. Ultrasound of neck with Submental approach will be used to assess tongue base thickness, subcutaneous fat thickness, retropalatal diameter, retroglossal diameter and upper airway length during normal tidal expiration, forced inspiration and muller's maneuver

DEVICE

Polysomnography

Full-night PSG will be performed in the sleep laboratory according to protocol of sleep medicine department after US assessment. Apnea will be defined as the absence of airflow ≥10 sec and hypopnea will be defined as \>50% decrease in airflow ≥10 sec associated with reduced arterial oxygen saturation by 4%, or an arousal. These two parameters are collectively defined as apnea-hypopnea index (AHI). An arousal will be recorded if there is a 3-second or longer abrupt shift in electroencephalogram frequency to alpha or theta or above 16 Hz, following at least 10 seconds of sleep, and, if arising in rapid eye movement sleep, there should be a rise in electromyographic tone. An independent technician blinded to the US results will analyze the sleep studies. Episodes of AHI per hour will be used to diagnose and grade the severity of OSA: Non-OSA : \< 5/hr mild OSA : 5- 14/hr moderate OSA :15-29/hr and severe OSA : ≥30/hr.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788149 on ClinicalTrials.gov