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Personalized Therapy Comfort Settings (PTCS)

by ResMed · Based in United States → — The World Leader in Sleep Health

Pulmonology Sleep Medicine

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Overview

Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, is an AI-enabled digital medical device developed by ResMed. It is designed to recommend individualized comfort settings for Continuous Positive Airway Pressure (CPAP) therapy, primarily for individuals with obstructive sleep apnea (OSA). This innovative tool leverages proprietary machine learning algorithms, trained on over 100 million nights of de-identified, real-world sleep data, to provide personalized recommendations.

Smart Comfort aims to help new CPAP users adjust to therapy faster and more comfortably, thereby improving confidence and long-term adherence. It considers factors such as age, gender, and Apnea-Hypopnea Index (AHI) to suggest non-prescription comfort settings like ramp speed/start pressure and expiratory pressure relief.

The system is integrated with ResMed’s myAir™ consumer sleep companion app and AirSense™ 11 devices, streamlining user setup and follow-up for clinicians by reducing the need for manual adjustments. It is important to note that these comfort settings support CPAP therapy device usage and do not alter prescribed therapy settings or efficacy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI-enabled personalized comfort settings for CPAP therapy
Leverages machine learning algorithms
Uses de-identified real-world sleep data (over 100 million nights)
Considers user data such as age, gender, and Apnea-Hypopnea Index (AHI)
Recommends settings like ramp speed/start pressure and exhalation relief
Aims to improve CPAP therapy adherence
Provides non-prescription comfort settings (does not alter prescribed therapy)
Integrates with ResMed myAiru2122 app and AirSenseu2122 11 devices
Streamlines user setup and follow-up for clinicians

Use Cases

Helping new CPAP users adjust to therapy faster and more comfortably
Improving long-term adherence to CPAP therapy
Reducing manual adjustments for clinicians in CPAP setup and follow-up
Personalizing CPAP comfort settings based on individual patient data
Supporting CPAP therapy device usage without altering prescribed therapeutic pressure

What Physicians Need to Know

Evidence Base

Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, leverages proprietary machine-learning algorithms trained on over 100 million nights of de-identified, real-world sleep data. The algorithms analyze patterns across user data, considering factors like age, gender, and Apnea-Hypopnea Index (AHI). This data-driven approach aims to provide personalized comfort settings beyond generic presets. The FDA submission was supported by retrospective real-world evidence.

Clinical Validation Studies

The FDA submission for PTCS (Smart Comfort) was supported by retrospective real-world evidence. This evidence showed that ResMed AirSense 10 and 11 users whose comfort settings matched Smart Comfort recommendations had higher engagement and sustained therapy adherence compared to those using default settings. These findings suggest that personalized comfort adjustments can improve the therapy experience without compromising efficacy. A retrospective observational analysis reviewed home telemonitoring data from de-identified patients with OSA from the US who received PAP therapy with an AirSense 10 device. This study aimed to evaluate a causal machine learning model to recommend personalized comfort settings for PAP therapy and investigate if these recommendations could improve CMS-defined adherence and therapy usage. There is also a double-blind, randomized, parallel assignment clinical trial with 66 patients (18+ years old, newly diagnosed with OSA and indicated for CPAP therapy) to determine if customizing comfort settings can improve CPAP compliance.

Clinical Workflow Integration

Smart Comfort is designed to work with ResMed's connected ecosystem, integrating with the myAir app and compatible ResMed devices like the AirSense 11. This aims to streamline user setup and follow-up, potentially reducing the need for numerous manual adjustments by clinicians. It helps standardize the comfort settings workflow and builds user confidence in personalized settings. The myAir app allows users to learn and adjust key comfort settings like humidity, pressure relief, ramp time, and tube temperature from their phone.

Physician Tip

Smart Comfort (PTCS) is an AI-enabled tool that recommends personalized, non-prescription comfort settings for CPAP therapy, such as ramp timing and exhalation relief, based on sleep data and individual characteristics. It is not intended to alter prescribed therapeutic pressure but rather to enhance user comfort and support therapy adherence, particularly during the initial stages. Clinicians may find this tool helpful in streamlining user setup and follow-up, potentially reducing the need for frequent manual adjustments and allowing more focus on clinical decision-making and patient support. The system aims to help patients adjust to therapy faster and more comfortably, which can improve confidence and overall health. Always remember that these are comfort settings and do not change the prescribed therapeutic pressure or efficacy of the treatment.

Smart Comfort is part of ResMed's connected, personalized sleep-health ecosystem. It integrates AI, cloud-connected ResMed devices (specifically the AirSense 11), and digital tools like the myAir app. The myAir app allows for control of Air11 PAP device comfort settings and remote operation via Bluetooth. It also provides a Nightly Timeline for therapy data and a digital sleep coach, Dawn, for support and insights. The system can also pair with compatible NightOwl home sleep apnea test devices over Bluetooth for diagnostic data upload.

At a glance

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Details

Category	Clinical Decision Support & Reference, Patient Engagement & Education
Pricing	Unknown
Mobile App	MyAir app
Training	Unknown
Compliance
BAA Available	Unknown
HIPAA Compliant	Unknown
FDA Status	Unknown
Integrations
EHR	Not specified
Specialties	Pulmonology, Sleep Medicine

Support & Reliability

Training Provided

Unknown

What the Web Says

ResMed's Personalized Therapy Comfort Settings (PTCS), marketed as "Smart Comfort," is an AI-enabled software accessory for ResMed PAP therapy devices, cleared by the FDA in December 2025. It uses machine learning, trained on over 100 million nights of sleep data, along with user-specific data like age, gender, and AHI, to recommend individualized, non-prescription comfort settings. This feature is designed to help new CPAP users adjust faster and more comfortably to therapy, improving confidence and overall health, and is rolling out in a limited beta for new AirSense 11 and myAir users in early 2026.

Overall: Positive

Strengths

Helps new CPAP users adjust faster and more comfortably to therapy.
Improves patient confidence and overall health.
Leverages a vast amount of sleep data (over 100 million nights) for personalized recommendations.
Can suggest settings like ramp speed, start pressure, and exhalation relief.
Retrospective evidence showed higher engagement and sustained adherence among users with Smart Comfort recommendations.
Streamlines user setup and follow-up for healthcare providers, potentially reducing manual adjustments.

Limitations

Not intended to alter prescribed therapeutic pressure settings or efficacy.
Limited beta rollout in early 2026 for new AirSense 11 and myAir users, with broader availability later.
No clinical data; bench testing only, with model performance validated using retrospective datasets.
Some Reddit users express skepticism about AI's ability to provide optimal settings without extensive individual data collection.
The exact comfort settings involved and their specific labels are not always clearly identified in available information.
The device-sync workflow for accepting recommendations and transmitting changes to the AirSense 11 is not fully documented.

Based on reviews from: thecpapshop.com, emergenresearch.com, hmenews.com, innolitics.com, sleepreviewmag.com, uscpap.com, sistemmacpap.com, reddit.com, stocktitan.net

Last updated: 2026-10-31

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Press & Coverage

resmed.com

ResMed Receives FDA Clearance for Personalized Therapy Comfort Settings, to be Marketed as Smart Comfort, an AI-Enabled, Digital Medical Device That Helps Personalize CPAP Therapy

ResMed announced it received FDA clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort, an AI-enabled medical device designed to personalize CPAP therapy. This device aims to help people with obstructive sleep apnea (OSA) start and stay on CPAP therapy by recommending individualized comfort settings. Smart Comfort is expected to launch in early 2026 in a limited U.S. beta version for new users of myAir paired with an AirSense 11 device, with a broader rollout later in 2026.

2025-12

sleepreviewmag.com

FDA Clears AI-powered Smart Comfort to Personalize CPAP Comfort Settings

The FDA has granted 510(k) clearance for ResMed's Personalized Therapy Comfort Settings, to be marketed as Smart Comfort, an AI-enabled medical device that recommends personalized comfort settings for CPAP therapy. The device uses real-world sleep data and machine-learning algorithms to help AirSense 11 users with obstructive sleep apnea improve engagement and adherence. It will be launched in early 2026 as a limited U.S. beta version.

2025-12

hme-business.com

ResMed Announces FDA Clearance for AI Device to Support Sleep Therapy Regimens

ResMed has received FDA clearance for its Personalized Therapy Comfort Settings (PTCS) device, which will be marketed as Smart Comfort, to assist individuals with obstructive sleep apnea using CPAP therapy. This AI-powered device will launch in early 2026 as a limited beta in the U.S. for new myAir users with AirSense 11 devices, aiming to improve therapy adherence.

2025-12

ht-medicaldevices.com

ResMed Secures FDA Clearance for AI-Powered Personalized CPAP Device

ResMed has obtained FDA clearance for its Smart Comfort personalized therapy solution, previously submitted as Personalized Therapy Comfort Settings (PTCS). This AI-enabled medical device is designed to recommend individualized comfort settings to help people with obstructive sleep apnea (OSA) initiate and maintain CPAP therapy. A limited U.S. beta release is anticipated in early 2026, targeting new users of the myAir app in conjunction with the AirSense 11 device.

2025-12

mpo-mag.com

ResMed Wins FDA Nod for AI-Powered Personalized CPAP Therapy

ResMed has received FDA clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort, an AI-enabled medical device that recommends personalized comfort settings for CPAP therapy. The device leverages machine learning algorithms and over 100 million nights of de-identified sleep data to help OSA patients start and remain on therapy.

2025-12

respiratory-therapy.com

FDA Clears ResMed Smart Comfort for CPAP Therapy

ResMed has received FDA clearance for its Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort, an AI-enabled medical device for obstructive sleep apnea (OSA) patients using CPAP therapy. Smart Comfort aims to improve adherence by recommending personalized comfort settings based on machine-learning algorithms and real-world sleep data.

2025-12

oup.com

Personalizing PAP Comfort Through AI-enabled Modeling: Retrospective Insights and Future Directions

This peer-reviewed article discusses Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, an FDA-cleared AI-enabled medical device that provides personalized PAP comfort setting recommendations. Retrospective analyses using de-identified ResMed PAP therapy datasets from 1.4 million patients showed that model-guided comfort settings were associated with improved PAP device usage and patient-reported early therapy experience.

2026-05

thecpapshop.com

What is ResMed's New "Smart Comfort" Feature?

ResMed's new "Smart Comfort" feature, officially known as Personalized Therapy Comfort Settings (PTCS), is an AI-driven tool cleared by the FDA to recommend personalized non-prescription comfort settings for CPAP therapy. This feature, debuting in 2026, aims to support users during the initial stages of therapy by suggesting optimal settings like ramp speed and exhalation relief, based on sleep data and individual characteristics.

2026-03

Videos

Product demos, reviews, and walkthroughs for Personalized Therapy Comfort Settings (PTCS).

Sleep Apneas vs Hypopneas vs RERAs - What's the Difference!?

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Frequently Asked Questions

What is Personalized Therapy Comfort Settings (PTCS) and how does it work?

Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, is an AI-enabled medical device cleared by the FDA that recommends personalized comfort settings for CPAP therapy. It uses machine learning algorithms trained on over 100 million nights of de-identified, real-world sleep data, along with user information like age, gender, and AHI, to suggest individualized settings such as ramp timing and exhalation relief. This aims to help patients with obstructive sleep apnea (OSA) initiate and adhere to CPAP therapy by enhancing comfort without altering prescribed therapeutic pressure or efficacy.

How does PTCS impact patient compliance and therapy adherence?

PTCS is designed to improve patient compliance and long-term adherence by addressing common therapy issues like comfort and mask fit early on. Retrospective real-world evidence submitted to the FDA showed that users whose comfort settings matched Smart Comfort recommendations had higher engagement and sustained therapy adherence compared to those using default settings. By personalizing comfort settings, the goal is to help patients adjust faster and more comfortably to CPAP therapy, thereby increasing confidence and overall health outcomes.

What are the limitations of PTCS in clinical decision support?

PTCS focuses on recommending non-prescription comfort settings to support CPAP therapy device usage and does not alter prescribed therapy settings or therapy efficacy. It is intended to streamline user setup and follow-up, reducing the need for manual adjustments, so clinicians can focus more on clinical decision-making and patient support. While it enhances comfort, it does not replace the physician's role in prescribing therapeutic pressure or managing the overall treatment plan for obstructive sleep apnea.

Are there alternatives to PTCS or other methods for improving CPAP comfort?

While PTCS offers an AI-driven approach to personalized comfort, other methods for improving CPAP comfort include manual adjustments of settings like ramp time and expiratory pressure relief (EPR) by clinicians. Patients may also find comfort improvements through different mask types, proper mask fit, and humidification options. Alternatives to CPAP therapy itself for obstructive sleep apnea include lifestyle changes, oral appliances, surgical options, and other positive airway pressure variants like BiPAP and ASV devices.

What is the pricing or reimbursement structure for PTCS?

ResMed's PTCS (Smart Comfort) is a feature designed to work with ResMed AirSense 11 devices and the myAir app. Information regarding specific pricing for PTCS as a standalone feature is not available. However, physicians can bill for services related to CPAP management and data review using various CPT codes, such as 94660 for CPAP initiation and management, or evaluation and management codes for office visits. Remote monitoring CPT codes (e.g., 99091, 99453, 99454, 99457, 99458) may also apply for the collection and interpretation of physiologic data, though Medicare may bundle some of these into other services.