Sleepiz One+

by Sleepiz  · Based in Switzerland → — Contactless Monitoring for Senior Care
Geriatrics Pulmonology Sleep Medicine
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Regulatory Status Disclosed

Overview

Sleepiz One+ is an FDA-cleared, contactless remote patient monitoring device that utilizes radar technology to collect biometric data and record vital signs from a patient’s bedside. It provides comprehensive respiration and heart rate monitoring for chronic conditions, including sleep apnea screening. The device is designed for ease of use, allowing for quick installation and seamless data transmission via a cellular module. It measures macro and micro-motions from heart contractions and breathing patterns with medical-grade accuracy, transforming these signals into actionable data using proprietary AI. Sleepiz One+ aims to provide patient-centric disease management through seamless integration of contactless monitoring into people’s homes, offering an alternative to traditional, often cumbersome, diagnostic methods like polysomnography. It is intended for use by healthcare professionals in clinical settings or by patients and their caregivers in a home environment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Contactless monitoring (radar technology)
  • Measures respiration rate
  • Measures heart rate
  • Sleep apnea screening
  • Remote patient monitoring
  • AI-powered data analysis
  • Web application for data access and analysis
  • Easy setup and deployment
  • Clinically validated
  • HIPAA compliant

Use Cases

  • Long-term monitoring of chronic respiratory diseases
  • Sleep apnea diagnosis and screening
  • Early detection of patient deterioration
  • Hospital at Home programs
  • Clinical trials and research studies
  • Senior care and assisted living facilities

What Physicians Need to Know

Cardiac Monitoring Integration
Sleepiz One+ is a contactless medical device that measures heart rate and respiration rate in adult patients at rest or during sleep. It integrates with Remote Patient Monitoring (RPM) and clinical study platforms, allowing healthcare professionals to access overnight vital sign data and presence logs via the Sleepiz cloud software for retrospective review and patient management.
Arrhythmia Detection Accuracy
The device measures heart rate with a 96% accuracy rate compared to gold standard methods.
AHA/ACC Guideline Alignment
While not explicitly stating alignment with AHA/ACC guidelines, the continuous monitoring of heart rate and respiration rate is crucial for assessing overall patient health and detecting early deterioration, which aligns with the principles of proactive cardiovascular care.
Physician Tip

Sleepiz One+ offers a valuable tool for contactless, long-term monitoring of heart rate and respiration rate, particularly beneficial for remote patient monitoring and clinical studies. Its high accuracy in vital sign measurement can aid in the early detection of physiological deterioration. Physicians should note that while it provides continuous data for review, it is not designed for real-time alarming in acute, life-threatening situations. It can be particularly useful for patients with chronic conditions, including cardiovascular and respiratory diseases, to track disease progression or remission and enable timely interventions.

The Sleepiz One+ seamlessly integrates into Remote Patient Monitoring (RPM) and clinical study platforms, providing healthcare professionals with access to comprehensive respiration and heart rate monitoring capabilities. Data is accessible via the Sleepiz cloud software for retrospective review and patient management. The device can also optionally integrate with additional Bluetooth devices, such as SpO2 sensors, to enhance monitoring capabilities.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentWall-mounted or bedside table placement, Wi-Fi connectivity
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Geriatrics, Pulmonology, Sleep Medicine

What the Web Says

The Sleepiz One+ is a contactless, radar-based device designed for monitoring sleep and respiratory events, particularly sleep apnea, in a home environment. It measures heart rate, respiration rate, and breathing patterns without requiring physical contact with the user. The device has received FDA clearance and is marketed for remote patient monitoring and clinical trials, especially beneficial for immobile or infectious patients.

Overall: Positive

Strengths

  • Contactless monitoring, enhancing patient comfort and reducing disruption to sleep.
  • Clinically validated for diagnosing moderate to severe Obstructive Sleep Apnea (OSA), with high sensitivity and specificity, especially when combined with an SpO2 sensor.
  • Easy to set up and use at home, making it convenient for patients and potentially reducing the need for in-laboratory polysomnography.
  • Provides continuous data for clinicians, offering insights beyond spot-check measurements and aiding in early detection of changes in respiratory rate.
  • Can be used for remote patient monitoring, allowing physicians to gain better insight into patients' physiological status over time.
  • Potential to reduce healthcare costs by offering a home-based alternative to expensive and resource-limited polysomnography.

Limitations

  • Struggles to distinguish between sleep and wakefulness, which is essential for accurate AHI estimation.
  • Not indicated for active patient monitoring, emergency alarms, or life-threatening situations.
  • Not suitable for individuals with active electronic implanted devices like pacemakers.
  • Some data sets were excluded from validation studies due to technical issues or poor signal quality.
  • The device should only complement, not replace, professional medical judgment.
  • No specific reviews from G2 or Capterra were found, and Reddit discussions primarily focused on general sleep apnea devices rather than the Sleepiz One+ specifically.

Based on reviews from: Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea - PMC, Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea - PubMed, Sleepiz | Contactless Monitoring for Senior Care, (PDF) Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea - ResearchGate, Sleepiz launches contactless device for remote patient monitoring in the United States; appoints Robb LaChappelle as VP for the U.S. - PR Newswire, Sleepiz sleep analysis: so easy to use, so complex in the background - Galaxus, FDA Clears Sleepiz's Contactless Remote Patient Monitoring Device, my review of sleep apnea devices/strategies, and tips for monitoring : r/SleepApnea - Reddit, Sleepiz Launches Contactless Device for Remote Patient Monitoring, SLEEPIZ AG Reviews - Trustpilot, Packages | Sleepiz.com, Best at home sleep device for tracking sleep or apnea : r/Biohackers - Reddit, Support | Sleepiz.com, Anyone know a cheap sleep tracker that has at least some what detailed sleep oxygen reporting? - Reddit, EMS Device - Anyone Tried it? : r/SleepApnea - Reddit, Device to track sleep apnea : r/SleepApnea - Reddit, Best Medical IoT Software: User Reviews from August 2026 - G2

Last updated: 2026-10-01

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Press & Coverage

Medical Product Outsourcing
FDA Clears Sleepiz's Contactless Remote Patient Monitoring Device
Sleepiz received FDA 510(k) clearance for Sleepiz One+, a contactless device that measures vital signs for remote patient monitoring and clinical studies. This clearance allows physicians to prescribe the device for home monitoring and seek reimbursement using CPT codes.
2023-12
Medical Device Network
Sleepiz wins FDA clearance for device that measures vitals during sleep
The Sleepiz One+ device, utilizing radar technology and AI, has received FDA Class II 510(k) clearance for contactless monitoring of breathing patterns, respiration rate, and heart rate during sleep. This allows physicians to prescribe it for sleep apnea screening and vital sign monitoring at home.
2023-10
GlobeNewswire
Sleepiz AG Lands FDA 510(k) Clearance for Contactless Remote Patient Monitoring Device Measuring Vital Signs - GlobeNewswire
Sleepiz announced FDA Class II 510(k) clearance for its Sleepiz One+ device, enabling contactless vital sign monitoring for early detection of deterioration in patients with chronic medical conditions. The device boasts 99% accuracy in breathing rate and 96% in heart rate measurements compared to gold standard methods.
2023-10
Physician's Weekly
FDA Clears Bedside Device for Contactless Remote Patient Monitoring
The FDA has granted 510(k) clearance to the Sleepiz One+, a contactless remote patient monitoring device that collects biometric data and records vital signs from a user's bedside table during sleep. This allows for home monitoring of patients with chronic respiratory diseases and reimbursement via CPT codes.
2023-10
PubMed (Sleep and Breathing)
Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea
A study published in Sleep and Breathing (May 2024) validated the Sleepiz One+ as a diagnostic tool for moderate to severe Obstructive Sleep Apnea (OSA), showing strong correlation with polysomnography (PSG) and high sensitivity and specificity, especially with an added SpO2 sensor.
2024-05
PR Newswire
Sleepiz launches contactless device for remote patient monitoring in the United States; appoints Robb LaChappelle as VP for the U.S.
Sleepiz registered its Sleepiz One+ contactless respiration and heart rate measuring device with the FDA in July 2022, paving the way for its use in remote patient monitoring and clinical trials in the United States. The device offers continuous, contactless monitoring of vital parameters.
2022-07
PubMed (Sleep and Breathing)
Home-based sleep monitoring using a novel non-contact, radar-based biomotion sensor in adults with cystic fibrosis treated with elexacaftor/tezacaftor/ivacaftor
A study published in Sleep and Breathing (September 2025) evaluated the Sleepiz One+ for monitoring respiratory rate, heart rate, AHI, and sleep quality in adults with cystic fibrosis during ETI therapy, demonstrating its reliability in tracking respiratory and sleep changes.
2025-09
PMC (Scientific Reports)
Clinical validation of a contactless respiration rate monitor
A clinical study published in Scientific Reports (March 2023) validated the Sleepiz One+ respiration monitor against a thoracic effort belt, showing excellent agreement for instantaneous breathing rate and respiratory rate statistics in both controlled and natural sleep settings.
2023-03

Videos

Product demos, reviews, and walkthroughs for Sleepiz One+.

View all on YouTube

Frequently Asked Questions

Sleepiz One+ utilizes a radar-based, non-contact sensor to monitor vital signs like breathing and heart rate during sleep. Its AI algorithms analyze these physiological signals to detect sleep apnea events, including central and obstructive apneas, and can provide insights into heart rate variability, which is relevant for assessing cardiovascular strain during sleep.
The Sleepiz One+ is designed for home use, with data automatically uploaded to a secure cloud platform. Physicians can access comprehensive reports through a dedicated portal, which include sleep stages, apnea-hypopnea index (AHI), heart rate trends, and oxygen desaturation events. The reports are structured to provide clear, actionable insights for cardiology patients.
Sleepiz One+ offers a non-contact, unobtrusive alternative to traditional PSG, which can be cumbersome. While PSG remains the gold standard for comprehensive sleep studies, Sleepiz One+ provides validated accuracy for detecting sleep apnea and offers continuous heart rate monitoring, which can be particularly useful for cardiology patients. It aims to improve patient compliance due to its ease of use compared to other HSATs.
Pricing details for Sleepiz One+ are typically provided upon inquiry to Sleepiz directly, as they can vary based on volume and specific clinic needs. Regarding reimbursement, it's essential to check with local and national coding guidelines, as the landscape for AI-powered home monitoring devices is evolving. Sleepiz may offer guidance on applicable CPT codes for home sleep apnea testing.
While Sleepiz One+ is effective for detecting sleep apnea and monitoring heart rate, it may have limitations in precisely characterizing complex cardiac arrhythmias or other highly specialized cardiac conditions that require direct ECG monitoring. It's generally suitable for a broad patient population, but physicians should consider individual patient needs and comorbidities when determining its appropriateness.
Sleepiz One+ adheres to strict data security and privacy regulations, including GDPR and HIPAA compliance. All data is encrypted during transmission and storage, and access is restricted to authorized personnel. The AI processing is performed on anonymized data where possible, and robust safeguards are in place to protect patient information.
Sleepiz provides comprehensive technical support and training resources for healthcare professionals. This includes user manuals, online tutorials, and dedicated support channels to assist with device setup, data interpretation, and integration into clinical workflows. They aim to ensure physicians can confidently and effectively use the device for their cardiology patients.

Compare Sleepiz One+

VS
VitalRhythm vs Sleepiz One+
Cardiology AI Adjacent · 65/100
VitalRhythm and Sleepiz One+ are adjacent competitors in remote patient monitoring, both utilizing AI for health data analysis. VitalRhythm focuses on continuous cardiac arrhythmia detection via a wearable…
VS
Study Watch with Irregular Pulse Monitor vs Sleepiz One+
Cardiology AI Adjacent · 65/100
Both tools are FDA-cleared for remote patient monitoring and collect biometric data, but they differ significantly in their primary focus and deployment. The Verily Study Watch is a…
VS
Tempus ECG-AF vs Sleepiz One+
Cardiology AI Adjacent · 65/100
Tempus ECG-AF and Sleepiz One+ are adjacent tools, both leveraging AI and focusing on cardiac health in geriatrics, but with distinct applications. Tempus ECG-AF is designed for in-facility…
VS
AI-ECG Platform vs Sleepiz One+
Cardiology AI Adjacent · 65/100
The AI-ECG Platform is designed for in-depth, AI-powered analysis and diagnosis of 12-lead resting ECGs, focusing on specific cardiovascular diseases. In contrast, Sleepiz One+ offers contactless remote patient…

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Suggest an Edit → | Report an issue | Last Verified: 2026-07-01 | First Added: 2026-07-01

Investors who backed Sleepiz One+

Funded through the company that built this tool.

Poli Angels
Angel Network AI T2
Sao Paulo, Brazil
<$250k
Poli Angels is a Sao Paulo-based angel network composed primarily of alumni from the engineering school of the University of Sao Paulo…
Health IT / Healthcare Software Medical Devices / MedTech
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