N/A Completed N=52 Diagnostic

Validation of Sleep Apnea Screening Device

Obstructive Sleep Apnea

Source: ClinicalTrials.gov NCT02814227 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcomePrimary: Specificity — 71.4 percentage of true negatives

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.