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Diagnostic Device

Polysomnography for Obstructive Sleep Apnea

N/A
Waitlist Available
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test if neck ultrasound is a reliable tool for identifying characteristics of obstructive sleep apnea and discriminating its severity.

Eligible Conditions
  • Obstructive Sleep Apnea

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anthropometric measurement
Ultrasonographic exam of neck to measure of static and dynamic predictors of obstructive sleep apnea
polysomnography

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: STUDY GROUPExperimental Treatment2 Interventions
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.
Group II: validation groupActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polysomnography
2018
N/A
~1890
Ultrasound Exam
2016
N/A
~40

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
299 Previous Clinical Trials
2,098,747 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for participants in this experiment?

"The information hosted on clinicaltrials.gov evidences that this trial is not enrolling patients at present, with its last update being made back in May 26th 2016. Despite this fact, there are currently 291 other studies actively recruiting test subjects."

Answered by AI
~0 spots leftby Mar 2025