Apneal Lite

Wake up tired or snore? Apneal is a CE-marked Class IIa medical device that uses your smartphone at home to screen for and aid in the diagnosis of sleep apnea.

WAKE UP TIRED? DO YOU SNORE? Apneal is a CE-marked Class IIa medical device that uses your compatible smartphone to assess sleep and breathing at home. Daytime sleepiness, loud snoring, restless sleep, gasping or breathing pauses can have many causes. Sleep apnea may be one of them — and it can go unnoticed.

MORE THAN A SLEEP SCORE Apneal goes beyond wellness trackers and risk-only screening. It analyzes sound and movement signals recorded during the night and provides medical information that supports sleep apnea screening and aids diagnosis.

ONE NIGHT. YOUR SMARTPHONE. A CLOSER LOOK AT YOUR SLEEP. The app guides you to secure your smartphone over a thin T-shirt using the specified adhesive or cohesive bands, start the recording and sleep in your own bed. Positioned on your chest, the phone uses its microphone and motion sensors to capture signals related to breathing, movement and sleep. No watch, ring or separate electronic sleep sensor is required.

Apneal analyzes:

• Breathing disturbances during sleep
• Apnea-Hypopnea Index (AHI)
• Sleep apnea severity: normal, mild, moderate or severe
• Snoring
• Heart rate
• Sleeping position
• Movement and sleep/wake periods
• Recording quality

The AHI is the number of apneas and hypopneas per hour of sleep and is used to classify sleep apnea severity. ​ VALIDATED AGAINST POLYSOMNOGRAPHY Apneal’s AHI performance was evaluated in 432 adults against polysomnography (PSG), the reference sleep examination. At the AHI ≥15 events/hour threshold used to identify moderate-to-severe sleep apnea, Apneal demonstrated 91% sensitivity and 91% specificity compared with PSG.

A SIMPLER PATH TO ASSESSMENT Conventional home sleep tests usually require dedicated equipment. Apneal uses your own compatible smartphone, which may help simplify access to home assessment and facilitate timely follow-up when needed.

APNEAL MAY BE RELEVANT IF YOU:

• Wake up tired or unrefreshed
• Feel unusually sleepy during the day
• Snore regularly or loudly
• Wake repeatedly during the night
• Wake with a choking or gasping sensation
• Have been told that your breathing pauses while you sleep

Paid access is required to complete the assessment and access your report.

YOUR HEALTH DATA IS PROTECTED Your health data is encrypted and securely hosted in Europe. Recording files are removed from your phone after secure upload. Apneal is developed under an ISO 13485-certified quality management system and handles personal data under applicable GDPR requirements.

IMPORTANT MEDICAL INFORMATION Apneal is intended for adults aged 18 and over with sleep complaints. Apneal is a Software as a Medical Device designed to measure physical and physiological sleep parameters, with the aim of screening and aiding in the diagnosis of Sleep Apnea Hypopnea Syndrome (SAHS). Apneal is not intended to replace full polysomnography when additional physiological parameters are needed. Apneal provides automated analysis to support screening and aid diagnosis. Clinical judgment by a qualified healthcare professional is required. Do not rely solely on the report to self-diagnose or make treatment decisions. A negative, inconclusive or technically inadequate result does not rule out sleep apnea. If symptoms persist or worsen, seek medical advice. Polysomnography or another appropriate assessment may be required. Do not use Apneal if you have an active implantable medical device. Read the Instructions for Use for all contraindications, warnings, limitations and conditions of use.

REGULATORY INFORMATION Class IIa medical device, CE marked (CE 2797) under Regulation (EU) 2017/745. Registered in EUDAMED under the trade name “Apneal Pro”. Manufacturer: Mitral SAS, 8 rue Jean Antoine de Baïf, 75013 Paris, France SRN: FR-MF-000043597 | UDI-DI: 0303760406360036 email: support@apneal.ai eIFU link: www.apneal.ai/manual CE certificate number : MDR 814248 Clinical study: EASY – C23-80 (Inserm IDRCB 2023-A02144-41) © 2026 Mitral – Apneal®. All rights reserved.