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Validation of Sleep Apnea Screening Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02814227
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Zansors
Information provided by (Responsible Party):
J. Todd Arnedt, University of Michigan

Study Description
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Brief Summary:
Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an estimated 18-40 million adults and 0.7-3% of all children in the US. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. The specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Zansors® sleep screening device Not Applicable

Detailed Description:

Obstructive Sleep Apnea (OSA) results in tiredness, depression and fatigue, and has several associated common comorbidities. It is believed that over 80% of OSA remains undiagnosed. Poorer and disadvantaged communities are at higher risk for sleep disorders, including OSA, even after accounting for other risk factors. The gold-standard method for diagnosing OSA is in-laboratory polysomnography; however, this procedure is generally available only to patients with health insurance due to its high cost. As a result, communities at particularly high risk for OSA are less likely to have this serious sleep disorder appropriately diagnosed and treated.

An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. Zansors® has developed a bioengineered, semiconductor prototype that measures breathing and movement during sleep. It is a 1.5 x 2.5 x 0.2 inch wireless package using four key technologies:

  1. an adjustable microphone;
  2. a 3-axis accelerometer;
  3. embedded algorithms to measure sleep events; and
  4. acrylic adhesive.

The product will be designed as an FDA-approved over-the-counter device that the patient can wear during sleep and wake up with a color score of red, yellow, or green depending on their sleep apnea status. The features of this product include that it is home-based; easy to use; non-invasive; wireless; disposable; low cost ($20-50); and presents easily understandable test results. However, such a device must first be validated against gold-standard polysomnography.

The specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Wireless Sensor Patch for Reducing Barriers to In-home Sleep Apnea Screening
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zansors® sleep screening device
Zansors device compared to overnight polysomnography
 Device: Zansors® sleep screening device
Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography


Outcome Measures
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Primary Outcome Measures :
  1. Specificity [ Time Frame: 8 hours ]
    Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: 8 hours ]
    Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals

  2. Positive Predictive Value (PPV) [ Time Frame: 8 hours ]
    PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals

  3. Negative Predictive Value (NPV) [ Time Frame: 8 hours ]
    NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be over 18 and referred by medical staff for an overnight assessment for suspected sleep apnea

Exclusion Criteria:

  • Pregnancy
  • Heart disease including congestive heart failure or a pacemaker
  • Breathing disorder (emphysema or chronic obstructive breathing disorder)
  • Neurological disorder such as Parkinson's Disease
  • Restless leg syndrome or Periodic limb movement
  • Allergies to metal
  • Pre-existing skin conditions where sensor would be attached
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814227


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Zansors
Investigators
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Principal Investigator: J. Todd Arnedt, PhD University of Michigan
More Information
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Responsible Party: J. Todd Arnedt, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02814227    
Other Study ID Numbers: R41MD008845-01 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2016    Key Record Dates
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: June 2017
Keywords provided by J. Todd Arnedt, University of Michigan:
obstructive sleep apnea screening device
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases