A pilot study of a wearable apnoea detection device

Area of Science:

• Medical Devices
• Sleep Medicine
• Respiratory Monitoring

Background:

• Current apnoea monitoring methods face limitations in availability, cost, accuracy, and ease of use.
• These challenges hinder effective patient monitoring for sleep-disordered breathing.

Purpose of the Study:

• To develop and clinically evaluate a novel, miniature medical device for apnoea monitoring.
• The device aims to overcome the limitations of existing diagnostic techniques.

Main Methods:

• A pilot study involved 20 healthy controls and 10 patients referred for sleep apnoea diagnosis.
• The novel wearable device's performance was compared against the FDA-approved SOMNO system.
• Both systems were tested during overnight sleep, with results compared to a blinded clinician's scoring.

Main Results:

• The wearable device achieved 88.6% sensitivity and 99.6% specificity for spontaneous apnoeas, compared to 14.3% sensitivity and 99.3% specificity for the SOMNO system.
• When including hypopnoea, the novel device showed 77.1% sensitivity and 99.7% specificity versus 54% sensitivity and 98.5% specificity for SOMNO.
• The device demonstrated robust performance even with breathing artefacts.

Conclusions:

• The novel wearable device shows performance comparable to expert clinical scoring for apnoea detection.
• This technology presents a potential solution for convenient and accurate home monitoring of sleep apnoea.
• Further studies are warranted to validate these findings in larger cohorts.