Here's background for our Evaluations of continuous positive airway pressure (CPAP) units, outlining the key considerations for making wise purchasing decisions. Learn how the technology is used, which specs are important and why, what factors we test for, costs of ownership, and more.
 

Overview

CPAP units are primarily used by patients in their homes to treat obstructive sleep apnea (OSA). They may also be used in the hospital or other clinical settings when brought from home by patients. If a patient requires CPAP but does not provide their own device, healthcare facilities may use other devices, such as low-acuity noninvasive ventilators, during the patient's stay.

To be considered in this category, a product must have the ability to maintain a constant pressure between 3 and 25 cm H₂O. It must also have no expiratory valve—expired gas is vented passively from the mask—and be intended for personal use by one patient on a consistent basis.

CPAP technology is mature. The treatment was first developed in 1980, with the first commercial devices receiving FDA 510(k) clearance in 1984. Since then, advancements in the technology have focused on:

1. Developing and improving algorithms to automatically detect sleep apnea and adjust the pressure setting according to the patient's needs (automatic positive airway pressure, also called AutoPAP or APAP)

2. Capturing and transmitting data to the patient (via mobile apps), to the prescribing physician, and to the insurance provider

3. Improving patient comfort by incorporating:

a) Ramp features that gradually increase the pressure setting as the patient falls asleep

b) Expiratory relief features that reduce the pressure slightly at the end of each breath to make it easier for the patient to exhale

c) Humidification improvements, which include having integrated humidifiers that allow the patient to set the level of humidity directly on the CPAP unit (rather than having a separate humidifier) and heated tubing that prevents rainout.

Major components typically include the following:

1. Blower—the primary box that generates pressure; allows clinicians to program therapy and patients to adjust settings for improved comfort.

2. Humidifier—sometimes a separate device, but commonly a component of the CPAP unit itself; water reservoir that air passes through before going to patient. Most humidifiers are heated.

3. Circuit and mask—accessories that connect the CPAP device to the patient. These are generally not proprietary and therefore are not included in this Evaluation. Breathing circuit tubing may support heating capabilities to warm the air and avoid condensation within the tube. CPAP masks are available in three major types: full face, nasal, and nasal pillow.

Clinical applications: CPAP units are used to treat OSA during the patient's daily life. There is also evidence that CPAP units can be used to reduce risk for patients with CHF (congestive heart failure).

Facilities and clinical departments that would use this product include the sleep lab, the sleep medicine department of a hospital, long-term care and skilled nursing facilities, and med/surg, ICU, and other departments that admit patients. Durable medical equipment suppliers may provide these devices to patients with a prescription.

The primary users of the devices are patients with OSA. Sleep medicine doctors prescribe use of the devices and recommend therapy pressures. Respiratory therapists may train patients on the use of the device in a healthcare facility or in the patient's own home; they are also responsible for the care of hospital patients who require CPAP during their stay.

These products are referred to by a number of names. Devices that can deliver a very high therapeutic pressure during inspiration and a lower pressure during expiration are called BiPAP units, or Bilevel machines. Devices that automatically titrate pressure are called AutoPAP, APAP (automatic positive airway pressure), and VPAP (variable positive airway pressure) units, among other terms.

Ratings: Continuous Positive Airway Pressure Units  Click the device names below to view our complete findings for each model. Products are listed alphabetically by supplier. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​
Model	Rating	Where Marketed	Performance	Safety	Workflow	Patient Experience	Interoperability	Cybersecurity	Maintenance	User Experience	Cost of Ownership (Estimated) over Five Years
Metran JPAP Last updated 12/2019		Australia, Hong Kong, Israel, Japan, Jordan, Thailand, various European countries (not available in U.S.)	Good	Good	Excellent	Excellent	Not evaluated	Good	Good	Not evaluated	Good;                         $2,400/$1,500 with/without Hummax QE humidification system*
Philips Respironics DreamStation Last updated 6/2020		Worldwide	Good	Good	Excellent	Excellent	Not evaluated	Good	Good	Not evaluated	Good; $1,800**
ResMed AirSense 10 Last updated 6/2020		Worldwide	Good	Good	Excellent	Excellent	Not evaluated	To be determined	Good	Not evaluated	Good; $2,000**
Resvent iBreeze 20A Last updated 12/2019		Africa, Asia, Europe, Latin America, the Middle East, Oceania (not available in U.S.)	Good	Good	Excellent	Excellent	Not evaluated	Good	Good	Not evaluated	Good; $1,300***
Xiaoniu AS100A Last updated 12/2019		Australia, Chile, China, Greece, India, Thailand, Tunisia (not available in U.S.)	Good	Good	Good	Excellent	Not evaluated	Good	Good	Not evaluated	Good; $1,200***
* Based on prices for Hong Kong, a major market for the product; converted to U.S. dollars. ** Based on prices for the United States, a major market for the product. *** Based on prices for China, a major market for the product; converted to U.S. dollars.  ​ ​ ​ ​ ​ ​ ​ ​ ​

The following products compete directly with one another, and with the products in the table above.

3B Medical Inc.

• Luna II Series

Acare Technology Co. Ltd. [552744]

• COM-PAPII CPA Series

Apex Medical Corp. [322488]

• iCH Series
• XT Series

Byond

• Dreamy CPAP
• ResPlus CPAP

Canta Medical Technology Co. Ltd. [456209]

• AP/BP/CP Series

Drive DeVilbiss Healthcare Ltd. [515001]

• IntelliPAP Series

Fisher & Paykel Healthcare Inc. [255300]

• ICON+ Series
• SleepStyle

Fresca Medical

• Curve

Koike Medical Co. Ltd. [288635]

• Jusmine.J

Loewenstein Medical Technology GmbH + Co. KG [529503]

• prisma Series
• SOMNO Series

Philips Respironics Inc. [454161]

• DreamStation BiPAP autoSV
• DreamStation Go

ResMed Corp [177147]

• AirCurve 10 Series
• AirMini

SEFAM SAS [283338]

• S.Box
   

Our testing looks at what we believe are the important considerations when choosing a CPAP unit, as described below.

Performance

1. Pressure accuracy at minimum, maximum, and intermediate pressures

2. Data transfer capabilities

3. Compliance with air travel standards

4. Presence of an oximeter sensor

5. Clinical effectiveness of automatic pressure adjustment algorithms

Safety

1. Minimum pressure delivered (must be ≥3 cm H₂O)

2. Maximum pressure delivered (must be ≤30 cm H₂O)

3. Protection against unauthorized changes to therapeutic settings

4. Electrical safety

Workflow

1. Ability to store at least one month of data

2. Ease of use, as assessed by untrained test users

3. Ease of filling the humidifier reservoir

4. Presence of an integrated humidifier

5. Compatibility with a battery

6. Clear indicators of pressure setting, humidifier setting, and active special features

7. Wireless data transmission

Patient Experience

1. Operational noise level

2. Display brightness

3. Presence of a pressure ramp or advanced pressure ramp feature to improve patient comfort

4. Rainout prevention features

5. Expiratory relief feature

6. Presence of a mask fit test to detect leaks

7. Compatibility with heated tubing

8. Alarm clock functionality

9. Sleep report for the patient

10. Mobile application that can track and display patient sleep data

11. Automatic start, pause, and reset capabilities to pause therapy when the patient removes the mask and to restart therapy when the patient puts the mask on

Cybersecurity

We review the vendor responses to our standard cybersecurity questionnaire.

Maintenance

1. Ease of changing filters

2. Ease of cleaning and disinfection

3. Compatible cleaning and disinfection products

Cost of Ownership

We estimate the product's total cost of ownership, including capital and consumable costs, and compare it to the estimated total cost of ownership for a generic CPAP unit. 
 

Principles of Operation

1. CPAP units consist of a flow generator or "blower," a length of tubing, and a patient interface (typically a tight-fitting mask).

a) Commercially available CPAP face masks are available in various sizes and contours. They are typically made of a hard plastic outer shell with a soft inner flap seal of vinyl or silicone. They are typically held in place by elastic bands that go around the patient's head. Masks come in three varieties:

(1) Nasal pillows, which seal against the nostrils

(2) Nasal masks, which cover the entire nose

(3) Full-face masks, which cover both the nose and mouth

b) Most CPAP units can be used with a variety of mask types as long as the mask allows for passive ventilation of exhaled CO₂ through some form of vent. Noninvasive ventilation masks are not safe to use with CPAP units since they do not allow for passive venting. Masks may be included with the equipment purchase or sold separately. Most CPAP unit vendors also sell masks, but any mask can be used with any unit. The mask is often the most important component to patient acceptance of CPAP therapy.

c) The mask is attached to plastic tubing, which runs to the flow generator. The flow of air from the generator creates constant gentle pressure, ranging from about 3 to 20 cm H₂O, which prevents the airway from collapsing and obstructing the patient's breathing.

2. Power is typically supplied from an electrical wall outlet. Some units that are intended to be used during travel have an internal battery, and external battery packs are available from some CPAP vendors as well as third parties. At least one model can be paired with a solar panel for outdoor use.

3. CPAP units are simple to operate and have limited controls for the patient to access:

a) Humidity settings to avoid drying out the patient's nose, mouth, and airways

b) Tube-heating settings (when used with compatible tubing) to warm the air and avoid condensation in the tubing

c) Pressure ramp option that starts pressures at a low level (which is more comfortable for the patient), then slowly increases the pressure to the final prescribed level over a period of time (e.g., 15 to 30 minutes) as or after the patient falls asleep. For OSA patients, the pressure ramp feature can improve treatment compliance by making CPAP much more tolerable at night. CPAP units designed for use in sleep labs have additional features to facilitate patient testing and pressure adjustments.

d) Expiratory pressure relief option reduces the pressure slightly at the end of each breath to make it easier for the patient to exhale.

e) Auto on and auto off options start and stop the generator, respectively, making using the therapy as seamless as possible for the patient.

4. CPAP units also have more extensive control menus that can be accessed by a clinician. These menus allow the following:

a) Adjustment of therapeutic pressure settings

(1) For CPAP therapy, this is the set therapeutic pressure

(2) For APAP therapy, this is the lower and upper limits of the algorithm.

b) Enabling or disabling patient comfort features like ramp and expiratory pressure relief.

5. The patient should have a device that matches the nature and severity of their sleep apnea. Patients with apnea that varies with sleeping position could benefit from AutoPAP. BiPAP therapy could be beneficial for patients that require a high pressure to keep their airway open or who cannot tolerate CPAP at a moderate pressure; however, this type of home PAP therapy is not used frequently.

Normal Operating Procedure

1. The patient is diagnosed with sleep apnea in either the home or the sleep lab.

2. Once diagnosed, the pressure necessary to keep the airway open is determined via a titration study, typically in a sleep lab.

3. Depending on the nature and severity of the patient's sleep apnea, the physician writes a prescription for CPAP, BiPAP, or AutoPAP.

a) CPAP prescription will have a set pressure.

b) BiPAP prescription will have an inspiratory and expiratory pressure.

c) AutoPAP prescription will have a lower and upper pressure limit.

4. The patient selects a CPAP unit and mask.

a) In the United States, CPAP units and masks are handled by durable medical equipment (DME) suppliers.

b) In other regions, patients work directly with CPAP vendors or their distributors.

5. Device settings are configured according to the prescription.

6. Mask fitting can be done at the DME or vendor, in the sleep lab, or at home.

7. The patient sets up the CPAP unit at home, usually with support from the DME or vendor.

8. The patient turns on the CPAP unit at bedtime and connects the breathing circuit to the flow generator and to the mask. The patient dons the mask when they are ready to sleep.

9. The patient sleeps with the mask on and the CPAP unit delivering therapy. The positive pressure maintains an open airway. If the patient experiences a sleep apnea event, the device may record the event or increase the pressure slightly, depending on the settings.

10. In the morning, the patient removes the mask and turns off the CPAP unit. They may review a sleep report from the night, which includes data such as hours of sleep, number of sleep apnea events, and quality of the mask fit.

11. The patient should regularly clean the mask and breathing circuit. These accessories should be replaced every few months.

12. The patient should also replace filters in the CPAP unit every few months.

Safety

1. Since CPAP units rely on passive exhalation of expired gas through a vent, devices should never deliver less than 3 cm H₂O (since that is the pressure needed to flush exhaled gases between breaths).

2. Noninvasive ventilator (NIV) masks can look very similar to CPAP masks but, critically, do not have an exhalation vent. An NIV mask should never be used with a CPAP unit.

Understanding Product Specifications

The following factors are usually included in the specifications provided by manufacturers. We discuss these factors and their clinical significance. (ECRI's Healthcare Product Comparison System [HPCS] provides recommended values for a number of these specifications in its comparison chart for Positive Airway Pressure Units, Noninvasive. HPCS is available to members of the Health Devices Gold and SELECTplus programs.)

1. Modes

a) Type of therapy the unit can deliver to the patient

b) Units can deliver CPAP, BiPAP, AutoPAP, or some combination.

2. Monitored parameters

a) Patient parameters that the unit is capable of monitoring and displaying

b) Most units monitor respiratory rate, flow, pressure, and leak. Pressure is typically the only displayed parameter.

3. Noise level

a) How loud the unit is while in use

b) Most devices are less than 30 dB(A).

4. Low-flow O₂ inlet

a) Allows addition of supplemental oxygen with a concentrator or other low-flow source for patients who require the support

b) Most devices have a low-flow oxygen inlet, possibly as an optional configuration.

5. Humidifier

a) Increases the humidity of the air to improve patient comfort

b) Integrated humidifiers (in which the amount of humidity can be controlled directly on the CPAP unit) are typical. 

The data represented in the charts is based on ECRI's Health Devices Alerts records from January 2015 to November 2019 and represents seven total alerts. 

In addition, the following reports relate specifically to the COVID-19 pandemic:

• H0587 [COVID-19] Use of Consumer-Grade Obstructive Sleep Apnea Devices May Supplement Ventilator Supply during Shortage [ECRI Exclusive Hazard Report]
• S0398 [COVID-19] Shortages of Intensive Care Ventilators—Strategies for Mitigation [ECRI Exclusive Special Report]