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Talk About Sleep proudly welcomes Fisher & Paykel Healthcare as our special guest tonight (Tuesday September 10, 2002) to discuss the Oracle, a new, unique oral mask for the delivery of CPAP and Bi-Level therapy.
With us tonight is Fisher & Paykel's Jillian Gery, Interface Specialist for the U.S. market. Jillian has a BS degree in Biology from Ohio University and has been assisting sleeps labs across the country in setting patients up on the Oracle. She joined the Fisher & Paykel Healthcare team in 2002 in an effort to provide education for both the nasal and oral interfaces.
How is the Oracle different from other masks on the market?
The Oracle delivers pressure through a seal around the mouth rather than the nose and gives patients another interface choice.
How does CPAP delivery through the mouth work?
The Oracle seals around the mouth and delivers CPAP as the patient breathes in and out through their mouth only. During oral CPAP therapy, the pressure will push the soft palate towards the back of the throat, sealing off the upper airway and preventing air flowing out through the nose. Air is then directed down the airway, just as in nasal CPAP delivery.
Which patients are best suited for the Oracle?
Any patient can be a potential candidate for the Oracle. It is a great option for new CPAP users as well as patients who have struggled on other CPAP methods. Certain types of patients may especially benefit from Oracle usage including: claustrophobics, mouth breathers, patients with leaks/poor fit with current masks, and patients with nasal obstructions or pressure sores.
Is heated humidification required?
Yes.
How much heated humidity is required?
Patients requirements can vary and sometimes more heated humidity is required with the Oracle than with a nasal mask.
Why is heated humidification required?
This is due to the fact that the oral mucosa is unable to sufficiently heat and humidify the additional airflow supplied by CPAP.
How high do I need to set my heated humidifier when using the Oracle?
Fisher & Paykel Healthcare recommend starting your heated humidifier at ¾ of the maximum setting and adjusting up if necessary. Our integrated CPAP system (HC220/HC221) and our heated humidifier (HC150) contain a feature called Ambient Trackingä which adjusts the heater plate temperature in accordance with room temperature changes to provide the maximum humidity while minimizing condensation.
What happens if the Oracle is used with cool passover or no humidification?
Without heated humidification, the mouth and lips will dry causing discomfort to the patient and the patient may be unable to tolerate Oracle therapy. Cool passover cannot provide the amount of humidity that is required.
What are the benefits of using the Oracle?
Some of the benefits include: no headgear, minimal fitting, less intrusive, able to wear glasses, reduces claustrophobia, more freedom to move when sleeping, no mouth leaks, and a reduction in skin abrasions/pressure sores/nasal congestion.
Are the pressures the same between the Oracle and a nasal mask?
Studies have shown that the pressures between the two indicate general equivalency.
Are there patients that the Oracle is not recommended for?
Fisher & Paykel Healthcare cannot predict Oracle success in the following patients: UPPP or Naso-oral surgery (no soft palate), Macroglossia (enlarged tongue), Retrognathia/Abnormal dentition (Recessed jaw/buck teeth/misalignments), TMJ, and the Oracle is contraindicated in patients with Bruxism (teeth grinding).
Does the Oracle come in different sizes?
Yes. The SoftSeal, which fits into the mouth, comes in two sizes- Standard and Small to accommodate a large range of patients.
What is the difference between the Standard and Small SoftSeals?
The small softseal has a narrower shield which fits between the teeth and the lips and a shorter tongue guide.
What are the components of the Oracle?
The SoftSeal is a silicone shield, which inserts into the mouth between the teeth and the lips. The tongue guide rests above the tongue to prevent the tongue from blocking the CPAP flow. The SnapFlap snaps over the outside of the mouth to help secure the Oracle with the inner shield. The flexitube contains bias flow ports and snaps onto the SnapFlap to attach to the CPAP tubing.
What material is the Oracle made of?
Implantable grade medical silicone and plastic.
How do you change the SoftSeal size on the Oracle?
Pull the seal over the ridge on the top and the bottom of the plastic molding and pull it off the back of the Oracle. Fit the alternate SoftSeal onto the plastic grooves on the molding and pull the seal over the top and bottom ridges to secure it in place. Make sure that the arrows are pointed upwards on both the SoftSeal and the SnapFlap.
What adjustments can be made on the Oracle for different mouth or lip sizes?
There are two sizes (Standard and Small) of the SoftSeal which fits inside the mouth. In addition, there are three different adjustments that can be made to the SnapFlap distance to accommodate for different lip sizes.
How does the Oracle stay in the mouth?
A seal is created between the shield on the inside of the mouth that fits between the teeth and the lips and the outside flap that secures over the mouth. This holds the mask in place when CPAP is applied.
Does the tongue guide hold the tongue down?
No. It rests above the tongue to prevent it from rising up and blocking CPAP flow.
Does the Oracle have headgear?
No.
How are adjustments made to the SnapFlap to account for different lip sizes?
Rotate the gold ring on the front of the SnapFlap counterclockwise in the direction of the arrow. While holding firmly to the back of the Oracle, adjust the SnapFlap in and out to the desired setting and rotate the SnapFlap back counterclockwise to lock in new position.
Do you bite down on the Oracle?
No. The Oracle floats in the mouth when CPAP is applied.
I have red marks on my face when using the Oracle- what should I do?
This is an indication that the SnapFlap is too tight- try loosening it.
Can the Oracle fall out of the mouth?
It shouldn't. If it does, it is because the SnapFlap is too loose. The SnapFlap should be adjusted to a tighter setting. Make sure that the Standard SoftSeal is being used as well.
Is there a recommended SoftSeal size to start with?
The Standard size should be used first. If gum irritation or a gagging feeling occurs, change to the Small size.
How should the Oracle be cleaned at home?
Cleanse in a solution of antibacterial mouthwash (Listerine) and water and allow to dry.
How much does the Oracle cost?
The suggested retail price for the Oracle is $169.95. Please shop around your local homecare companies for the best price.
The Oracle is available to homecare companies with proper education and training. Contact your local homecare company to check available stock and inform them of your interest in our product.
What are the most common complaints when using the Oracle?
Many patients complain of a dry mouth which can be combated with proper heated humidification levels in most cases. Some patients experience increased salivation when first beginning Oracle therapy- this is temporary and should subside in a few days.
If dry mouth is a side effect of Oracle therapy, what should be done?
The setting on the heated humidifier should be increased to provide the most humidity possible. If rainout occurs, insulate the tubing to prevent this. If moisture is in the tubing, it means that the patient is not receiving it and this can contribute to the dry mouth.
I have my humidifier set at the maximum setting and still am experiencing dry mouth, what can I do?
Make sure that there is no rainout in the tubing on the maximum setting. In addition, make sure that the Oracle is properly assembled with both arrows up and that no nasal leak is present. Finally, in extreme cases, saliva substitutes can be purchased over the counter at local pharmacies which can provide extra moisture for the mouth when used in conjunction with the Oracle.
Is excessive salivation an issue with the Oracle?
No. Some patients may experience increased salivation when first using the Oracle due to the fact that it is a new object in the mouth and can cause a drying sensation which triggers a salivary response. However, this is usually temporary and should go away within a few days of extended usage.
When using the Oracle, is it possible for air to leak out of the nose?
Yes. Some patients are unable to have a perfect seal with their soft palate. In this case, pressure may need to be modified or nasal plugs can be used to seal off the nasal route. These nose plugs are available from Fisher & Paykel Healthcare.
What do you do if you have a nasal leak?
First, make sure that air is leaking out of your nose while you are sleeping. When awake, it is possible to breathe through your nose because you have muscle tone. When asleep, the body relaxes and the nasal route closes. It is important to differentiate the two different situations. If air is leaking out while asleep, nose plugs are available to combat this.
Is it possible it breathe through your nose while on the Oracle?
Yes....when awake it is easy and comfortable to breathe through the nose. When asleep, the soft palate relaxes and seals off the nasal route. Patients are encouraged to breathe through their mouth only when using the Oracle- although nasal breathing is possible.
Can patients cough when using the Oracle?
Yes.
Can the Oracle be used with Bi-Level therapy?
Yes.
Can the Oracle be used with auto-titrating units?
The Oracle should work effectively with auto-titrating units.
How do I know if I have a nasal leak?
Usually, a leak will arouse you during the night due to the discomfort. A bed partner may hear the leak while you are asleep. Another indication is an extremely dry mouth due to the increased flow from the CPAP to compensate.
I feel a fluttering in the back of my throat when trying to fall asleep on the Oracle. What is this and how do I stop this from occurring?
This sensation or noise may be due to a nasal leak. Another possibility is that you are having difficulty transitioning between oral and nasal breathing. You are fighting to do both and this causes the fluttering as you switch between the two routes. Nasal plugs can be used temporarily to train your breathing patterns to use the mouth only and eliminate the occurrence of the fluttering.
Is the Oracle an oral appliance?
No. The Oracle is a mask and does not require orthodontic fitting. It is not a mandibular advancement device.
Are there ideal pressures for Oracle usage?
Patients have been successful at all pressure ranges.
How do you snap the elbow on and off the Oracle?
To attach the elbow, you need to apply pressure at an angle until it clicks into place and can rotate. To detach the elbow, hold the Oracle in one hand and with the other pull the elbow upward at an angle with force.
How do you comfortably insert the Oracle into your mouth?
It is easiest to slide one side of the SoftSeal along the front of your teeth into one side of your mouth. Then using your other hand, fold the other side of the SoftSeal to slide in front of the teeth on the other side of your mouth and insert it in. Remember to "pucker" your lips around the SoftSeal before shutting the SnapFlap for the best seal. It may help to slide the Oracle in if the mouth and lips are moistened first.
Which direction should the arrows be facing?
The arrows on the SoftSeal and on the SnapFlap should always be pointing upwards.
Can the Oracle be used with all CPAP machines and heated humidifiers?
The Oracle is compatible with most manufacturers' equipment.
What is the purpose of the holes on the front of the SnapFlap?
These are to allow the skin to breathe underneath the SnapFlap.
Where are the exhalation ports located on the Oracle?
They are located on the bend of the elbow of the flexitube.
What is the best way to introduce a patient to the Oracle for the first time?
It is ideal to preheat the humidifier at least 10 minutes before introducing the Oracle to a patient. Demonstrate how to fit the Oracle and show the Oracle video if possible. Have the patient lie down with a pressure of 5 cm H2O for maximum comfort. Remind the patient to breathe in and out of their mouth only, not to bite on the Oracle, and make sure that both sets of arrows are pointed upwards.
Can the Oracle be used with dentures?
Yes. It can be used with dentures in or out.
Can the Oracle be used with supplemental oxygen?
Yes. We have oxygen ports which can attach to the tubing on the Oracle.
Yes- but it does not rotate freely. It can rotate but is meant to stay where the patient positions it.
When using the Oracle, my cheeks seem to "puff" out....is this normal?
The "puffing" out of the cheeks is due to the pressure being applied through the mouth and is quite normal for Oracle users.
Does the Oracle cause jaw or gum pain?
It shouldn't. However, if it does you may want to change to the Small SoftSeal. In addition, make sure that the patient is not clenching or holding the Oracle in their mouth- it should "float". Also look for factors such as Gingivitis or TMJ.
Is the Oracle uncomfortable in the mouth?
Due to the fact that this is a new sensation, it may take patients two or three days for users to feel at ease with the Oracle in the mouth. Make sure that the Oracle is the right way up with the arrows pointed upwards.
What is the purpose of the Oracle Certification Program?
This program was created for sleep labs and homecare dealers to provide the proper education and training when using the Oracle. This ensures the greatest patient success when administered properly.
How has the success rate been with the Oracle?
Great. It has been very successful in both new CPAP users as well as "rescue" patients.
Do I need to go back to a sleep lab to get re-titrated if I want to use the Oracle?
If you have the ability to return to the lab, I would recommend it. This allows the patient to know if the Oracle is right for them and to troubleshoot any issues from the start. However, it is not required and an Oracle can be obtained directly from a homecare company at the patient's request or need.
Can the Oracle be used successfully with a beard or a mustache?
Definitely. However, some patients may require an adjustment to a tighter SnapFlap setting to create a better seal.
Will the mask give me problems with allergies and congestion?
Rhinitis, nasal congestion and allergies are just some of the symptoms alleviated by oral CPAP delivery.
The unique Fisher & Paykel Healthcare combination of SoftSeal and SnapFlap ensures that no mask leaks will disturb a good nights sleep.
Will the mask move when I change positions?
No. With no complicated straps or headgear to adjust, users can enjoy freedom of movement all night.
Will I be able to easily put the Oracle on?
The Oracle uses the unique strapless SnapFlap eliminating the need for headgear and custom fitting.
Is the Oracle noisy or drafty?
The Bias Flow arrangement (located on the elbow of the flexitube) minimizes draft and noise for both user and bed partner.
Will the Oracle cover my face and feel claustrophobic?
The Oracle has no strapping, so it doesn't obstruct your vision and minimizes the effects of claustrophobia.
Yes- it can be assembled in seconds, is comfortable, easy to use and easy to clean and maintain.
Can you use a chin strap with the Oracle?
We do not recommend it. Patients should not require chin straps due to the fact that the Oracle seals securely into the mouth and is an ideal mask for mouth breathers.
What is the most important thing to remember when using the Oracle?
Heated humidification.
Is the Oracle more difficult to travel with due to the fact that it requires a heated humidifier?
No. The benefits of heated humidification have been established for both nasal and oral CPAP users. It is an essential component of any patient's CPAP therapy regardless of the device. For travelers, check out our HC220/HC221 integrated CPAP with heated humidifier- this small unit makes traveling with a humidifier extremely easy and convenient.
How tight does the SnapFlap need to be?
It should be tight enough to prevent the Oracle falling out or leaking, but not so tight as to cause discomfort. Start the fitting on the middle setting.
Should you detach the components of the Oracle for cleaning?
Yes.
Is there a difference in compliance between patients on nasal masks and patients on the Oracle?
There appears to be no significant difference in compliance with nasal masks and the Oracle. It is important to remember that this is an alternative mask for patients wishing to be successful on CPAP therapy.
Will the Oracle cause irritations to the face under the SnapFlap?
It shouldn't. If this is observed, make sure that the Oracle is being cleaned in a Listerine/Water solution as recommended. Many times irritations can be attributed to improper cleaning solutions being used.
When should a patient try using the Oracle?
If the patient is a current CPAP user who is experiencing problems with compliance due to mask problems- the Oracle is a great option. It is also a viable option for new CPAP users if they find the Oracle to be more comfortable. This will improve compliance from the start and help patients to stick with CPAP therapy beyond the first couple months or weeks.
Is there discomfort because the Oracle blows air directly into the throat?
No. On the plastic molding of the Oracle where the flow is directed through- it is bifurcated. This allows the air to splint as it flows into the mouth which spreads it throughout the back of the throat while still maintaining a patent airway.
If I am experiencing a nasal leak, what other options do I have if I am not comfortable with the Fisher & Paykel Healthcare nose plugs?
I do not recommend swimmer's clips unless they are very soft and won't irritate or cause sores on the nose. Many patients have found success using foam ear plugs which they insert into their nose instead. These are inexpensive and have the ability to seal most leaks.
Is it difficult to swallow when using the Oracle?
It can be a little more difficult. The tongue is not free to move as easily to circulate saliva. Most patients do not have an issue with this- but for those that do, it is only a matter of time before they acclimatize to this.
Can you use the ramp mode on your CPAP machine with the Oracle?
Yes.
What are the nose plugs like that Fisher & Paykel Healthcare manufactures?
The plugs come in 3 sizes- small, medium, and large. The plugs are attached in a horseshoe shape and each side slides up into each nostril. It eliminates the leak by sealing the nostrils. When inserted, it looks like a nose ring and fits over the SnapFlap of the Oracle.
Do many patients gag when using the Oracle due to the tongue guide?
No. It happens on occasion, but not often. When it does- change to the Small Softseal. If a patient is unable to tolerate the Small size, then the Oracle is not a mask that will work for them successfully.
Yes.
What has the patient feedback been to the Oracle?
Great! I have patients that contact me with their success stories constantly. For those that are struggling, I work with them personally to allow them to be as successful as possible. This is a wonderful mask and I look forward to hearing from each of you with your own personal success stories!
View the Oracle and other Fisher & Paykel Healthcare products in the Talk About Sleep Equipment Fair
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