Validation of a new wearable device for type 3 sleep test without flowmeter
Mauro Contini1, Antonio Sarmento2, Paola Gugliandolo1
1Centro Cardiologico Monzino, IRCCS, Milano, Italy.
Plos One
|April 16, 2021
Summary
This study shows that the X10X and X10Y wearable systems can accurately detect and classify sleep apnea events, offering a comfortable alternative to traditional sleep test instrumentation.
Area of Science:
- Sleep Medicine
- Respiratory Physiology
- Medical Device Technology
Background:
- Traditional sleep monitoring devices often cause patient discomfort due to flowmeter use.
- Accurate detection of sleep apnea events is crucial for effective treatment.
Purpose of the Study:
- To evaluate the efficacy of the innovative wearable X10X and X10Y systems.
- To determine if these devices can detect and classify sleep apnea severity without a flowmeter.
Main Methods:
- Simultaneous recording of X10X/X10Y and a certified Type 3 system (SOMNOtouch) in 40 patients.
- Evaluation of respiratory signal quality, apnea/hypopnea duration, and classification accuracy.
Main Results:
- High agreement (grades 4-5 in 383/580 cases) and correlation (r2=0.921) between X10X/X10Y and SOMNOtouch.
- Accurate classification rates for obstructive (72.3%), central (81%), hypopneas (61.3%), and mixed apneas (64.6%).
Conclusions:
- X10X and X10Y devices provide accurate sleep respiratory disorder grading without nasal cannula flow measurement.
- These wearable systems are suitable for Type 3 sleep testing and screening.
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