Ultrasound Against Obstructive Sleep Apnea

NCT02788149 | Withdrawn DMC

• 1 other identifier: HFHREVIEW
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Obstructive Sleep Apnea

Keywords

Ultrasonography; Submental; Lateral Parapharyngeal wall; Tongue base thickness; Polysomnography

Outcome Measures

Primary Outcomes (3)

• Ultrasonographic exam of neck to measure of static and dynamic predictors of obstructive sleep apnea

  Investigators will measure Lateral parapharyngeal wall thickness (cms), upper airway length(cms), tongue base thickness(cms), subcutaneous fat thickness(cms), Retropalatal diameter(cms), Retroglossal diameter(cms) during normal tidal breathing as static indicators. Investigators will also measure tongue base thickness(cms), subcutaneous fat thickness(cms), Retropalatal diameter(cms), Retroglossal diameter (cms) during forced inspiratory maneuver and muller's maneuver as dynamic indicators. All measurements will be taken 3 times and mean will be reported. Investigators will calculate the percentage change in the above mentioned predictors during muller's maneuver Investigator will assess the predictive value of these variables in patients with obstructive sleep apnea, as diagnosed by Polysomnography.

  1 Year

• polysomnography

  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). 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.

  1 year

• Anthropometric measurement

  Demographic data, including age, gender, weight (kilograms), body height (centimeters) and neck circumference (NC), will be recorded by a trained assistant in the sleep clinic. Weight and height will be recorded with the patients wearing light clothes, but no shoes. Body mass index (BMI) will be then calculated as weight (kg) divided by height squared (m2). NC will be measured (in cm) with a flexible tape at the level of the cricothyroid membrane after a gentle expiration by the subject while standing upright. History of hypertension, diabetes, hyperlipidemia or any other cardiovascular diseases will be recorded according to medical records or statements by the patients. All participants will be asked to complete the Epworth Sleepiness Scale (ESS), a subjective self-reported measure of excessive daytime sleepiness, within the same session before the ultrasound examination.

  1 year

Study Arms (2)

STUDY GROUP

EXPERIMENTAL

Model development group: This group will get Ultrasound of neck exam followed by polysomnography. We will use this group to identify the ultrasonographic parameters that have strong association of predicting obstructive sleep apnea. We will use these these predictors to estimate the patient's probability of severe OSA, which then will be used to test the receiver operating characteristic (ROC) curve of diagnosing severe OSA. The optimal cut-off value of the ROC curve will be defined as the one with the least (1 - sensitivity)2+ (1- specificity)2 in the model-development group. This formula will then tested in the validation group.

Device: Ultrasound Exam; Device: Polysomnography

validation group

ACTIVE COMPARATOR

One third patients in the cohort will be randomly assigned to this group. This group will get ultrasound of neck exam followed by polysomnography. The predictors will be tested in his group.

Device: Ultrasound Exam; Device: Polysomnography

Interventions

Ultrasound Exam DEVICE

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

Also known as: Ultrasonography

STUDY GROUP; validation group

Polysomnography DEVICE

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.

Also known as: Sleep Study

STUDY GROUP; validation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged ≥18 years-old and who are arranged to receive polysomnography for suspected OSA, as per STOP BANG questionnaire, will be eligible for the study

You may not qualify if:

• Refusal to participate
• Inability to perform the maneuvers
• Presence of congestive heart failure
• Presence of chronic pulmonary disease demonstrated on pulmonary function testing
• Active neurologic event
• Active infection or surgery four weeks prior to screening
• Active inflammation in head and neck region
• Burns, trauma, radiotherapy involving head and neck region
• Other diagnosis of sleep disorders
• Ascites, benign or malignant abdominal mass and
• Pregnancy
• Craniofacial abnormalities
• Presence of severe nasal obstruction
• Oral cavity, Oropharyngeal or laryngeal masses
• Cervical rigidity with limited neck flexion and head extension

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Ultrasonography; Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: May 22, 2016
• First Posted: June 2, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)