N/A
N=52
Validation of Sleep Apnea Screening Device
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02814227 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Specificity — 71.4 percentage of true negatives
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zansors® sleep screening device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specificity |
71.4 | — |
| SECONDARY Sensitivity |
75 | — |
| SECONDARY Positive Predictive Value (PPV) |
0.692 | — |
| SECONDARY Negative Predictive Value (NPV) |
0.77 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02814227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.