ANNE Sleep Home Sleep Apnea Test
Strong Clinical Evidence
FDA 510(k) Cleared
Home Sleep Tests

ANNE Sleep Home Sleep Apnea Test

by Sibel Health Model: ANNE Sleep (510k: K220095)

92/100
Clinical Score
HSA/FSA: Usually Eligible

Key Features

Bio-Integrated Sensors: Soft, flexible, skin-mounted sensors designed for superior patient comfort compared to traditional belts.
Continuous Streaming: Streams real-time biosignals including ECG and PPG waveforms to an associated mobile platform.
Comprehensive Vital Signs: Tracks heart rate, respiratory rate, and SpO2 with clinically validated accuracy (SpO2 Arms ≤ 3%).
Ambulatory Monitoring: Designed for continuous physiological information collection on ambulatory patients in home settings.

Device Overview

ANNE Sleep is a wireless monitoring platform indicated for the collection, analysis, display, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders in adults. The system utilizes two skin-mounted, bio-integrated sensors placed on the chest and finger to measure heart rate, oximetry, and respiratory signals.

Technical Specifications

Model Number ANNE Sleep (510k: K220095)
Manufacturer Sibel Health
Connectivity
Bluetooth
Category Home Sleep Tests
Channels Monitored (airflow/effort/SpO2/position) Continuous measurements of SpO2, pulse rate, heart rate, peripheral arterial tonometry (PAT), snore, chest movement, and body position.
AHI Detection Range Full diagnostic range; calculates Sibel-AHI per hour of sleep as a diagnostic aid.
Recording Duration (nights) 10 hours of storage capacity for overnight diagnostic sessions.
Sensor Types Two skin-mounted, bio-integrated sensors (Chest and Finger) featuring 3-axis accelerometry and PPG.
Data Format & Export Transmitted wirelessly for display, storage, and analysis via the ANNE View application and cloud backend.
FDA Classification Class II, 21 CFR 868.2375 (Breathing Frequency Monitor, Product Code: MNR).
Board-Certified Interpretation Included Data is reviewed and interpreted by qualified healthcare professionals (HCP).
Prescription Requirement Yes, indicated for use under the direction of a Healthcare Professional.

Cost & Coverage Analysis

Pricing Breakdown

Disposable Adhesives (Single-use medical-grade adhesive stickers for chest and finger sensors.)
$25.00 / per test

HSA / FSA Eligibility

Usually Eligible

Eligibility may vary by provider and plan. Check with your HSA/FSA administrator for specific details.

Clinical Review

Evidence-based evaluation by medical professionals

"A soft, wireless wearable system that brings laboratory-grade sleep analysis to the home through innovative flexible sensor technology."
Strong Clinical Evidence Highly Recommended
92
Score

The ANNE Sleep system by Sibel Health represents a significant advancement in wearable sleep diagnostics, moving away from rigid hardware to flexible, epidermal electronics. Utilizing a wireless dual-sensor configuration, it records a comprehensive suite of physiological data including ECG, chest wall movement, peripheral arterial tonometry (PAT), SpO2, heart rate, and snoring. In a large multicenter clinical trial involving 225 subjects, the system demonstrated exceptional diagnostic accuracy for moderate and severe obstructive sleep apnea (OSA), showing 90% sensitivity and 98% specificity when compared to gold-standard polysomnography (PSG). A key clinical differentiator is its AI-enabled sleep-wake classifier, which uses deep learning to identify sleep stages and provide True Sleep Time, reducing the risk of disease underestimation common in Type III and IV tests that only measure recording time. The device is cleared by the FDA and is specifically designed to facilitate clinical-grade monitoring in both home and research environments.

Comparative Performance

Ranked #4 of 25 clinically evaluated home sleep tests devices

1
Withings Sleep Analyzer

Withings Sleep Analyzer

Withings

Top Rated
2
Sunrise Home Sleep Test

Sunrise Home Sleep Test

Sunrise SA

3
NightOwl Home Sleep Apnea Test

NightOwl Home Sleep Apnea Test

ResMed

4
ANNE Sleep Home Sleep Apnea Test

ANNE Sleep Home Sleep Apnea Test

Sibel Health

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92 /100

Clinical Context

Our #1-ranked home sleep tests device demonstrated superior performance across key clinical metrics. Compare detailed specifications to make an evidence-based selection.

Where to Buy

Verified retailers and current pricing

Sibel Health (Direct)

Varies by clinical contract

Available for clinical procurement; prescription required.

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Important Information

  • • Prices and availability subject to change
  • • Some devices may require a prescription
  • • HSA / FSA eligibility: Usually Eligible
  • • Purchase from authorized retailers for warranty protection
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