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Frequently Asked Questions

How It Works

WatchPATTM ONE is an FDA-cleared single-use home Sleep Apnea testing device that is very easy to use.
The WatchPATTM ONE is cleared by the FDA under K183559, trade name WatchPATTM ONE (WP1).
Yes, The American Academy of Sleep Medicine (AASM) guidelines for diagnosis of Obstructive Sleep Apnea support either in-center Polysomnography (PSG) or home sleep apnea testing with a device that meets their technical requirements, like the WatchPATTM ONE used in the Lunella service, for most adults without complicating health factors.

Shop carefully – there are irreputable on-line retailers who are selling sleep tests without a prescription, and not all home sleep test devices meet AASM guidelines. A sleep test, whether done in a sleep center or at home, must be prescribed by a medical doctor, and the results interpreted by a board-certified sleep physician.

Special note: During the COVID-19 outbreak, the American Academy of Sleep Medicine (AASM) and others have recommended that you avoid sleep centers if at all possible, and utilize home testing.
The answers that you provide ensure you qualify for a home sleep apnea test , and are used by a certified sleep physician, in conjunction with the results of your WatchPAT ONE test, to determine the best medical treatment for your condition.
Some insurance policies will only cover a sleep-center test, and some will cover that expense after you first meet the deductible of the policy. For example, if you have a $2000 deductible on your policy, and if the “covered” sleep center test cost is $1800, your out-of-pocket cost can be as high as $1800.
Yes! Lunella featuring WatchPAT™ ONE is eligible for Flexible Spending Account (FSA) and Health Savings Account (HSA) reimbursement. If you have an FSA or HSA card you can use it as a payment method in checkout.
The sensors used by the WatchPATTM ONE device in the Lunella service are one-time use, by design, so you can rest assured that you are the first and only patient to use the device.

Other in-home sleep tests are reusable, multi-use devices that must be returned to the sleep test provider to be prepared for use by the next patient, and are subject to charges for loss or damage to the device that can be thousands of dollars.

The WatchPATTM ONE in the Lunella service utilizes a smart phone to securely transfer your sleep activity over the internet to a secure location, where it is accessed by a certified sleep physician to interpret. With Lunella, you are not required to pay for damage or loss to the testing device, and you’ll know the device has been provided for your use only.
The WatchPATTM ONE records PAT signal, oxygen saturation of the blood, rest/activity cycles, an acoustic decibel detector for snoring evaluation, chest movement, body position and heart rate.
The PAT signal is recorded using a fingertip monitor that measures arterial pulse volume changes to help diagnose sleep disordered breathing.
The WatchPATTM ONE is indicated for use in patients 18 years and above.
Yes. The WatchPATTM should not be used in the following cases: use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study). Permanent pacemaker: atrial pacing or VVI without sinus rhythm. Sustained* non-sinus cardiac arrhythmias. * In the setting of sustained arrhythmia, the WatchPAT's automated algorithm might exclude some periods of time, resulting in a reduced valid sleep time. A minimum valid sleep time of 90 minutes is required for an automated report generation.
To be able to have a successful WatchPATTM ONE sleep study you must complete a Sleep Apnea screening assessment, and will need to have the WatchPATTM ONE device, a smartphone, the WatchPATTM ONE app, an assigned PIN and internet access (wifi or cellular).
You will need a smartphone (or tablet) that uses Android 5.1 and above or any iPhone with IOS 10 and above. WatchPATTM ONE is synced to the iPhone or Android phone via an app that is downloaded from the Apple App Store or Google Play Store. Like other apps, WatchPATTM ONE requires access to location and files on the smartphone. The app will request access to Bluetooth and will automatically turn this on if it is off. The app also requires 80MB of free space. Your phone needs to be connected to charger for the duration of the test. The app can be deleted after the study is completed.
The WatchPATTM ONE only requires access to your files, so that it can keep recording data during the test. Your photos and media remain secure and undisturbed.
The WatchPATTM ONE requires access to the location because this is a precondition for using the Bluetooth communication.
Yes, the WatchPATTM ONE can be used with a tablet as long as its operating system is Android 5.1 and above or IOS 10 and above.
It is recommended that you use the most reliable internet connection available. Note - if using a cellular connection, data charges from your subscriber's carrier may apply. Between 20-30MB of data will be consumed.
Based on your device type, search for the WatchPATTM ONE app either in Google Play for Android devices or the App Store for iPhones.
The test requires one night and, for a valid study, it is recommended that the WatchPATTM ONE record a minimum of six hours of sleep time.
For a valid study, it is recommended that you wear the WatchPATTM ONE for a minimum of six hours.
No, the WatchPATTM ONE device cannot be registered to anyone else prior to or after using.
The results of the risk assessment are immediately available to you and are automatically sent to Lunella's Board-Certified Sleep Apnea Physician Network for evaluation after you have completed your Lunella order. Lunella takes the privacy and security of your data seriously. Data handled by Lunella is treated appropriately as outlined in our Privacy Policy and Terms & Conditions.

Support

A PIN is created and assigned during the online order process and will be your month and year, MMYY, of birth (eg. DOB: March 1968 = PIN 0368)
After running the application, insert the AAA battery that is included in the box into the device.
The best conditions for the sleep test are when potential obstacles are taken out of the way. Before applying the WatchPATTM ONE, make sure to remove any tight fitting clothing. Also, remove rings, watches and other jewelry from the hand and wrist where you will be attaching the probes, as well as from your neck and chest. Remove nail polish and artificial nails from the test finger and make sure the fingernail is cut short. If needed, trim chest hair to ensure the chest sensor attaches to your skin. Make sure the room you are sleeping in is as quiet as possible during the night and turn off any possible noise sources. As the device consists of a snoring sensor, it is advised to sleep alone in the room. If you need some assistance in putting on the WatchPATTM device, have someone present to assist you.
No, you must remove nail polish and artificial nails from the test finger and make sure the fingernail is cut short prior to attaching the finger probe.
It is recommended that the finger probe be attached to the index finger of your non-dominant hand, but it can be attached on any finger except the thumb. For those with large fingers, you may use the small finger (pinky) for the finger probe.
Attach the chest sensor to your chest under the sternal notch (to the center of your upper chest bone, just below the front of your neck). To simplify, tilt your head forward so that your chin touches your chest. At the point where your chin touches your chest, attach the sensor.
During internet disconnection, your phone will not be able to transmit the sleep data. All the data will be stored in your phone. As soon as the internet connection is back up, your phone will start sending the sleep data.
Yes, please call Lunella Support at 1-833-586-3552.
During Bluetooth disconnection, WatchPATTM ONE will not be able to send the sleep data to your phone. Data will be kept in the WatchPATTM ONE until the Bluetooth connection is restored. As soon as the connection is back up, WatchPATTM ONE will send the sleep data to phone.
Approximately 6 hours of data can be stored on the WatchPATTM ONE device. When communication is resumed, the data transfer will continue.
During the night, your phone should be within 15ft/5m of the WatchPATTM ONE and be connected to the charger for the duration of the test. If you leave the room beyond the 15 feet or 5 meters for any reason, the WatchPATTM ONE will continue to collect data (provided it remains attached to your wrist, chest and finger). Once within range of 15 feet/5 meters, the WatchPATTM ONE will resync with the smartphone and data from the WatchPATTM will continue to be sent to the server.
Yes, you can use your phone as usual during the study. The phone should be connected to the charger for the duration of the test. Applications, such as an alarm clock, can be used and the WatchPATTM ONE application will run in the background.
You can accept the call or respond to the text without disrupting the study. The app syncs automatically and will continue to receive the study data.
When you turn on the WatchPATTM ONE by inserting the battery into the battery compartment, the self-diagnostic test is automatically performed for a few seconds and the LED in the center of the device will blink. If the WatchPATTM device passes the self-diagnostic test, the blinking light will have either a green color (if connection with the application has happened) or red blinking (until connection with the application happens). A solid red color will indicate that there is a hardware problem.
Yes, WatchPATTM ONE is a single-use device. After completing your sleep study, you can simply dispose of the device in accordance with local environmental laws and guidelines.
If you wake up in the middle of the night, but plan to continue sleeping, do not access the application. If you exit your bed for some reason, the application will re-establish the connection with your device once you return and the sleep test will continue uninterrupted. Do not remove the device and its sensors off your body, as this action will interrupt the test and it will not be possible to resume.
If the chest sensor falls off during the sleep study, you can simply reattach it without disrupting the test results.
If the finger probe is removed or falls off prior to completion of the sleep test study, it cannot be reattached. Please call Lunella support at 1-833-586-3552.
Wearing the WatchPATTM device should not cause any discomfort or pain. lease note the finger probe does require a tight fit and some pressure is normal. If you experience wrist, finger or arm discomfort, loosen the wrist strap. If the discomfort is not alleviated immediately, please call Lunella support at 1-833-586-3552.
No, do not let the device get wet.
No, you cannot pause the test to resume it at a later time. If you exit the application or remove any of the sensors from your wrist or finger, the test will be invalid. In the event that this happens, please call Lunella at 1-833-586-3552.
If you begin the test but are not ready to go to sleep, that is not a problem. The WatchPATTM ONE will record data for a total of 12 hours.
No. If you need some assistance in putting on the WatchPATTM device, have someone present to assist you.
Upon waking, and after 6 hours of recording, the app on your phone will display an "End Recording" prompt. Click "End Recording" button. You are not required to "turn off" the WatchPATTM ONE device itself. At this stage you should take off the device from your wrist, finger and chest. Sometimes, the last of the recording data still needs to be transmitted from the device, so before you close the application, wait for the confirmation of the completion of the test. Do not close the application while data is still uploading.
The expiration date is approximately 18 months after date of manufacture. Both the date of manufacture and expiration date are printed on the WatchPATTM ONE device label.
With the exclusion of alpha blocker and short acting nitrate medications, you can take your nightly medication as normal. If you have any questions about your medical condition or the medications you use, we recommend that you contact your physician prior to beginning the WatchPAT ONE study.

Prescription

A Board-Certified Sleep Physician will review and interpret your results before they are returned to you. This process typically takes approximately 1-3 business days, after which Lunella will send a secure link to the email address you provided where you will be able to download your results and the interpreted report. If your results indicate you may be experiencing severe Sleep Apnea or other abnormal results, a Care Coordinator will attempt to call you prior to the release of your results, which may delay result delivery by no more than 3 business days.
If you live in one of the following states (AR, AZ, DE, GA, ID, LA, MD, MN, MS, NH, NJ, NM, OK, VT, WV), a physician will attempt to contact you at the phone number you provided during the ordering process for a consultation prior to issuing a prescription for the WatchPATTM ONE. In all other states, a consultation is not required and a prescription for the WatchPATTM ONE will be issued to you by Lunella's physician network partners (subject to review of your risk assessment results). We will process your order for shipment as soon as the prescription is received (typically within 1-2 business days).
Your prescription will be automatically transmitted from the prescribing physician to Lunella once it is available and we will process your order for shipment within 1 business day. Depending on the shipping method selected, the device should arrive at your home within 1-5 business days.
PWNHealth is an independent physician network that provides physician services to you in connection with Lunella. PWNHealth services include clinical oversight of lab testing, including physician evaluation of test requests and ordering tests (if appropriate). These services are independent from Lunella and Itamar.
If for any reason you should need to talk to the authorizing physician network about your lab order, you may do so by calling PWNHealth at (888) 514-7199 between 9 AM - 5:30 PM EST to request.
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