Comparative Study of the ANNE One System to Diagnose Obstructive Sleep Apnea

  • STATUS
    Recruiting
  • End date
    Jun 30, 2021
  • participants needed
    300
  • sponsor
    Northwestern University
Updated on 27 January 2021

Summary

The main objective of this study is to evaluate the accuracy of the ANNETM One system for the diagnosis of obstructive sleep apnea (OSA) in adults.

Description

The main objective of this study is to evaluate the accuracy of the ANNETM One system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNETM One system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea. Our secondary hypothesis is that the ANNETM One system is non-inferior to home sleep apnea tests (HST) in the diagnosis of obstructive sleep apnea for patients who qualified for HST. Exploratory objectives include assessment of the diagnostic yield of the ANNETM One system worn over multiple sequential nights, repeatability of apnea-hypopnea index (AHI) calculations over multiple nights, and the predictive value of pulse arrival time to detect obstructive, central, and mixed apnea and hypopnea events.

Details
Condition Obstructive Sleep Apnea of Adult
Treatment ANNE One System
Clinical Study IdentifierNCT04643782
SponsorNorthwestern University
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Obstructive Sleep Apnea of Adult??
years old
Any gender
Any ethnic background
Subjects with suspected OSA based on history and physical who qualify for, and have HST ordered, as determined by their regular provider
Willingness to give written consent and comply with study procedures

Exclusion Criteria

An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection
Inability to understand instructions or operate device system
Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
Subject has a skin abnormality that precludes assessment
Subject has a history of dementia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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