Sleep Lab Technical Resources

FAQ INDEX

 

WINX® BACKGROUND

1) What is Winx?
2) How does Winx work?
3) How is Winx different than CPAP therapy?
4) Do patients need a prescription?
5) Is Winx effective?
6) How much does Winx cost?
7) Is Winx covered by insurance?
8) What parts need to be replaced, and how often?

PATIENT EVALUATION AND PSG STUDIES WITH WINX

9) How is the Winx Mouthpiece sized?
10) Why does the “Trial” Mouthpiece look a little different than the commercial version of the Winx Mouthpiece
11) Is titration required with Winx?
12) How do I prepare the Winx System and Console for a PSG study?
13) Can I display the Winx signals on my PSG System?
14) What should the Winx vacuum signals look like on my PSG System?
15) When should I intervene during a PSG study based on the vacuum signals?
16) Is there a way to test the PSG system without having to put a mouthpiece in someone’s mouth?
17) Can Winx be used with an HST System?
18) If the patient is using Winx for longer than one night, what cleaning is recommended?
19) What should I tell the patients to expect during their first night with Winx? Are there any discomforts?
20) What if the patient is having trouble achieving vacuum (i.e. getting the green light)?
21) Can Winx be used with a chin strap?
22) Is there anyone who is not a good candidate for Winx?

WINX IN YOUR LAB

23) Can any parts of the Winx System be reused or disinfected?
24) Should patients take the mouthpiece or other parts home from the sleep lab?
25) What information is stored on the SD Card in the back of the Winx Console? How can I see it?
26) How do I order more Winx sleep lab supplies?
27) Do you have clinical data available?
28) What other resources are available?

WINX TROUBLESHOOTING

29) Can I test to make sure the Winx console is functioning properly?
30) What should I do if the reservoir light is solid yellow?
31) Do you have any other troubleshooting materials?
32) What should we do if we suspect our Winx system is broken?
33) Do you have any additional customer support?

WINX BACKGROUND

 

1) What is Winx?

Winx is a new, nonsurgical device for use at home for the treatment of mild, moderate, and severe obstructive sleep apnea in adults. Winx consists of three main components – a small, quiet, console; a soft, flexible mouthpiece; and a slim tubing set. The mouthpiece is worn inside the mouth during sleep and is attached to the console with the flexible tubing set.

2) How does Winx work?

Patients wear a soft, flexible mouthpiece during sleep. Using Oral Pressure Therapy, the console creates a light oral vacuum that gently pulls the soft palate forward and stabilizes the tongue, increasing the size of the airway and allowing for natural breathing to occur during sleep.

3) How is Winx different than CPAP therapy?

  • Winx treats sleep apnea without using a mask. Instead, Winx uses a mouthpiece inside the mouth during sleep.
  • Winx’s tubing is long and flexible, allowing the user to sleep in any position.
  • The Winx console is very quiet.
  • The system is light, compact, and easy to operate. It also doesn’t require distilled water to run properly.

4) Do patients need a prescription?

Yes, the Winx product is available by physician prescription only.

5) Is Winx effective?

In clinical studies, Winx significantly improved the apnea-hypopnea index (AHI), a common measurement of sleep apnea severity, across adults with mild, moderate, and severe obstructive sleep apnea. Participants were highly compliant, using Winx for a median of six hours per night. Both participants and bed partners reported high satisfaction and preference for Winx over other therapy options. Not all patients will respond to Winx, but it is easy and inexpensive to evaluate. Patients should be evaluated to assess appropriate effectiveness.1 Evaluation methods can include PSG, HST, symptomatic evaluation, etc.

6) How much does Winx cost?

The cost of the Winx Sleep Therapy System will vary depending on insurance coverage. The cash price is comparable to CPAP.

7) Is Winx covered by insurance?

ApniCure, the manufacturer of Winx, is working with insurance companies to establish coverage for the product. Some insurance companies do cover Winx. Please contact Winx Customer Services at 888.9UN.MASK (888.986.6275) for additional information on coverage.

8) What parts need to be replaced, and how often?

To ensure optimal performance, the Winx Mouthpiece and Tubing should be replaced every 3 months. Winx Customer Services can help the patient with ordering replacement parts.

PATIENT EVALUATION AND PSG STUDIES WITH WINX

 

9) How is the Winx Mouthpiece sized?

Winx uses a soft, flexible mouthpiece that comes in 10 sizes. The mouthpiece size is determined by taking a bite wax impression of the patient’s teeth to determine the width and arc measurement of their mouth. These measurements can be quickly taken from a template provided by ApniCure to select the appropriate Winx Mouthpiece Size. For instructions on the process, please see the Winx Bitewax IFU, Winx Sleep Lab Console User Guide, and/or the instructional Winx videos.

10) Why does the “Trial” Mouthpiece look a little different than the commercial version of the Winx Mouthpiece?

In most all instances, a Winx Trial Mouthpiece with Tubing is used for short-term patient evaluation during an in-lab PSG or HST. The main difference between the Trial Mouthpiece with Tubing and the commercial version of the Winx device is that the connection between the mouthpiece and tubing has been removed to create an integrated mouthpiece and tubing set. This simplifies lab set-up and facilitates a more cost-effective trial of the Winx System. The mouthpiece portion of the device is exactly the same as the commercial version of the Winx Mouthpiece. Explain to patients that the Trial Mouthpiece is not intended for long-term use, and if they have not seen it already, show patients a sample of the commercial version of the Winx Mouthpiece and Tubing.

11) Is titration required with Winx?

There is no titration required. Winx delivers a constant negative pressure (51 cmH20) in the oral cavity, which was demonstrated to be effective and comfortable in clinical trials, while simplifying the in-lab testing process.

12) How do I prepare the Winx System and Console for a PSG study?

The Sleep Lab Console is designed to facilitate multiple, sequential patient use. The Sleep Lab Disposable Kit contains the Flow Connector and Reservoir that are replaced after each patient use. In addition, each patient should also receive a new Trial Mouthpiece with Tubing to ensure a clean and fresh system for evaluation. The console can be wiped down as needed. DO NOT submerge in water or use cleaning solutions to clean the console. Please see the Winx Sleep Lab Console User Guide or Lab Console Instructional Video for complete instructions.

13) Can I display Winx signals on my PSG System?

Yes, the Winx Sleep Lab Console can be connected to most common PSG systems using a Winx PSG Adapter Cable (provided by ApniCure). The Winx console measures two vacuum (pressure) signals that can be displayed on your PSG system for real-time monitoring during in-lab sleep studies:

  • Oral vacuum level: reflects the pressure at the mouthpiece, the most relevant signal to assess if a patient has an adequate vacuum level during a sleep study.
  • Pump vacuum level: indicator of how hard the pump is working to maintain the target oral vacuum level, can vary greatly during the night.

These vacuum signals are output as analog DC signals from Port “B” on the rear panel of the Winx Console. ApniCure can provide support with interfacing Winx with your PSG system.

14) What should the Winx vacuum signals look like on my PSG System?

The oral vacuum signal reflects the pressure in the mouth, and is the most relevant signal to assess adequate vacuum level during a PSG study. The oral vacuum signal should look fairly flat at the target vacuum level, right around 51 cmH20 (+/- 4 cmH20), when a proper seal is maintained. Unlike a pressure signal from CPAP, the oral vacuum signal will not pick up the patient’s breathing or respiratory cycle, and should look like a flat line instead of an oscillating signal. The pump vacuum signal gives an indication of how hard the pump is working to maintain the target vacuum level in the mouth. The pump signal will usually start somewhere between 51-80 cmH20, but can vary greatly during the night, often depending on how much saliva is in the tubing. It should always be greater than oral vacuum, and often gets progressively stronger throughout the night (i.e. the pressure value will increase) because the pump in the console has to work a little harder to maintain the correct target oral vacuum level as saliva gets into the tubing during the course of the night. For more detailed information on interpretation of the Winx vacuum signals, please see ApniCure’s PSG Training Materials.

15) When should I intervene during a PSG study based on the vacuum signals?

If the oral vacuum signal is not a nearly flat signal near the target vacuum (51 cm H20), check the flow connections and mouthpiece. If it reads a constant near 0 cmH20 for longer than a few minutes, the mouthpiece has likely fallen out of the patient’s mouth or is not situated properly in the patient’s mouth and should be readjusted. You can also see very brief drops to zero if the patient swallows, readjusts, etc., but in these cases, vacuum will re-establish on its own. Bruxing or swallowing can cause transient increases or decreases (spikes) in the oral pressure, which is normal. Please see the Winx Sleep Lab Console User Guide for more detailed instructions on product use and troubleshooting.

16) Is there a way to test the PSG system without having to put a mouthpiece in someone’s mouth?

Yes. ApniCure provides a Winx Test Loop that can be connected to the end of a Tubing Set, in place of a Winx Mouthpiece. The Winx Test Loop allows the Winx Sleep Lab Console to maintain vacuum at the target level (51 cmH20, the green light will be solid on the front of the console) without requiring a mouthpiece to be placed in a patient’s mouth. This can be very helpful for PSG set-up, training, and troubleshooting.

17) Can Winx be used with an HST System?

Winx can be used in Home Sleep Testing Evaluations. The Winx vacuum signals can be recorded if the HST system allows for auxiliary DC inputs. Otherwise, the console data that is stored on the SD card should be assessed with Winx Data Management Software to confirm that adequate vacuum level was maintained during the HST evaluation.

18) If the patient is using Winx for longer than one night, what cleaning is recommended?

The Winx Mouthpiece and reservoir should be rinsed with warm tap water after every use, and allowed to air dry for at least five minutes. The entire system should be flushed at least once per week. The system should NOT be cleaned with cleaning agents such as detergents, bleach, ammonia, alcohol or acids. Additionally, do NOT clean the mouthpiece in the dishwasher or with toothpaste, mouthwash or denture cleaner. Please refer to the Winx System User Guides or Patient Orientation Video for detailed instructions on cleaning and system maintenance.

19) What should I tell the patients to expect during their first night with Winx? Are there any discomforts?

Sleeping with oral pressure therapy creates a new sensation. Some patients will experience irritation or discomfort in the mouth (typically tongue, palate/ roof of mouth, gums, or “a slight sore/scratchy throat”), or mild tooth discomfort after the first night. This is normal during the adjustment period, and may last up to an hour or two after removing the mouthpiece. Typically these sensations go away entirely after one or two weeks using Winx. Some patients experience a dry mouth when initially using with Winx. Keeping a glass of water by the bed at night can help. Conversely, some patients may experience increased salivation at first (or in an awake state). Any excess saliva will be drawn through the tubing and into the reservoir. After one or two weeks, most patients are able to sleep soundly with Winx with no discomfort.

20) What if the patient is having trouble achieving vacuum (i.e. getting the green light)?

Some patients will be able to achieve vacuum almost immediately, and some will take a little longer to get used to the new sensation. To help achieve the proper vacuum, you can instruct the patient to lift their tongue to the roof of their mouth and swallow slowly. Once vacuum is achieved, they can relax their tongue, and the vacuum will hold it in place. Some patients have an easier time achieving vacuum in a relaxed, reclined position.

21) Can Winx be used with a chin strap?

If you determine that a patient has difficulty maintaining vacuum due to mouth opening or device retention during their PSG study, a chin strap is an option that you can try if you feel that it is appropriate for that specific patient.

22) Is there anyone who is not a good candidate for Winx?

The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults. Adequacy of nasal patency should be assessed, but a good rule-of-thumb is that patients should be able to breathe through their nose while sitting in a chair in an awake state. Being a “mouth breather” is not a contraindication for Winx; however effectiveness should be assessed. Adequacy of comfort of Mouthpiece fit should also be ascertained, including maintenance of oral vacuum during device use. The Winx Sleep Therapy System should not be used to treat central sleep apnea (CSA), or by anyone who:

  • Has a severe respiratory disorder, such as severe lung disease, pneumothorax, etc.
  • Has loose teeth or advanced periodontal disease.
  • Is under the age of 18.

Please see the Winx Sleep Lab System User Guide for additional information on contraindications, warnings and precautions.

WINX IN YOUR LAB

 

23) Can any parts of the Winx System be reused or disinfected?

The Winx Sleep Lab Console is designed for multiple, sequential patient use by disposal of the saliva contacting components (Trial Mouthpiece with Tubing, Reservoir, and Flow Connector) before a new patient uses the system. These components are single-patient use only and should be disposed of after the evaluation. The console can be wiped down as needed with a damp cloth. DO NOT submerge in water or use cleaning solutions to clean the console.

24) Should patients take the mouthpiece or other parts home from the sleep lab?

The Trial Mouthpiece with Tubing is not intended for long-term use at home beyond an evaluation period. If the patient decides to continue with Winx therapy, they will receive their own Winx Sleep Therapy System, including a commercial version of the Winx Mouthpiece, Tubing Set, and Reservoir. The Trial Mouthpiece does not connect optimally with the patient console that they will receive at home. ApniCure recommends that the Trial Mouthpiece with tubing be disposed of after patient trial.

25) What information is stored on the SD Card in the back of the Winx Console? How can I see it?

The Winx Console has internal software that tracks the use of the Winx system. Information can be accessed by physicians or sleep lab personnel by use of Winx Data Management Software provided by ApniCure. The information is downloaded via a SD card or micro B USB cable. The software can be used to generate a report showing a summary of the Winx console usage statistics, as well as a nightly display of the usage. To obtain data management software and SD cards, contact Winx Customer Services or your local Winx representative.

26) How do I order more Winx sleep lab supplies?

Winx Sleep Lab supplies can be ordered by completing a “Sleep Lab Order Form”, and sending it via email to Winx Customer Services or fax to 888.803.WINX (888.803.9469). You can also contact your local Winx representative.

27) Do you have clinical data available?

Yes, the Winx Sleep Lab Console User Guide contains clinical data from a study with the Winx System. Peer-reviewed manuscripts and abstracts can be found on our Winx Publications page.

28) What other resources are available?

Additional resources are available from your local representative. Instructional videos can be viewed on our Resources page.

TROUBLESHOOTING

 

29) Can I test to make sure the Winx console is functioning properly?

The Winx Test Loop can also be used to test that the console is functioning properly, without having to place a mouthpiece in someone’s mouth. With the Winx Test Loop connected to the console via the Winx Tubing Set, the console should achieve a constant green light on the front panel, indicating that it has reached the target vacuum level. If it does not, check for a console/tubing leak or system blockage. Please see the Winx Sleep Lab Console User Guide for more detailed information on system troubleshooting.

30) What should I do if the reservoir light is solid yellow?

This is an indication that the reservoir should be cleaned. The console will not run if the reservoir icon is solid yellow. Empty all saliva, and thoroughly rinse the inside of the lid with warm tap water. Remember to tighten the reservoir lid (by turning clockwise) before replacing the reservoir in the console. A small percentage of patients may experience saliva that is more “foamy” than normal (i.e. not a large volume of saliva, but the “foamy”-nature may set off the volume sensor in the reservoir). In these limited instances, a simethicone (GasX) strip provided by ApniCure may be placed into the reservoir, which should eliminate any subsequent issues. Please see the Winx Sleep Lab Console User Guide for more detailed information on system cleaning and troubleshooting.

31) Do you have any other troubleshooting materials?

Yes, please refer to the Winx Sleep Lab Console User Guide.

32) What should we do if we suspect our Winx system is broken?

Please contact Winx Customer Services at 888.9UN.MASK (888.986.6275) to report the problem. We will be happy to help solve the issue or send any replacement parts needed.

33) Do you have any additional customer support?

If you have any additional questions, please contact Winx Customer Services from 6am-6pm PST at 888.9UN.MASK(888.986.6275) or contact your local Winx representative.

REFERENCES: 1 Winx Sleep Lab Console User Guide