Sleep Medicine

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Hypoglossal Nerve Stimulator (Inspire®)

What is Inspire®?

Inspire® is a surgical treatment for obstructive sleep apnea and may be indicated in individuals who do NOT tolerate PAP therapy.  It delivers electrical stimulation to the tongue (via the hypoglossal nerve) to gently thrust the tongue forward out of the airway while you are asleep.   The goal is to keep the upper airway open while sleeping to prevent “breathing events”. The surgery is performed under general anesthesia but patients typically do not have to stay overnight in the hospital.  Inspire® is NOT as effective as PAP therapy so this procedure is only for individuals who struggle with PAP therapy.

How do I qualify for Inspire®?

Inspire is NOT for everyone.  You may qualify for the procedure if:

1. You do NOT tolerate PAP. 
2. Your body mass index (BMI) is less than 32 (though BMI up to 35 may be considered).
3. You must have moderate to severe sleep apnea with a baseline apnea-hypopnea index (AHI) between 15-65 events per hour.  Inspire does NOT treat central sleep apnea.

If you meet ALL the criteria above, you will be referred to the sleep specialist for an evaluation. 

If you do not meet any of the above qualifications, you will NOT be eligible for Inspire and will NOT be referred to the sleep specialist.

What should I expect during my visit with the sleep specialist?

The sleep specialist will review your sleep study and discuss options on how to treat your sleep apnea.  You may be required to repeat the sleep study if your sleep study is more than 2 years old or there is concern for other types of abnormal breathing during sleep. The sleep specialist will also discuss the risks and benefits of the procedure, success rate and side effects of Inspire®.  Individuals with other underlying sleep problems like insomnia or restless legs syndrome have been reported to have more difficulties with Inspire® so it is important that these are addressed/treated prior to getting the implant.

If you and the sleep specialist agree that Inspire® is a good option for you, you will be referred to the surgeon (ENT surgeon) to undergo a drug induced sleep endoscopy (DISE).  This procedure is necessary to verify that the tongue is causing the airway obstruction and that inspire® will treat your sleep apnea appropriately.

If I qualify for the implant, what should I expect?

You will have two surgical incisions:  one over your chest and the other under your jaw.  The generator which delivers the stimulation is implanted on your chest just below the collar bone.  A stimulation electrode is placed around the hypoglossal nerve of the tongue.  After the procedure, the device is OFF to let your body heal. 

What are the risks of the procedure? 

All surgeries have the potential to have complications.  These include the risk for infection and bleeding in the surgical site.   Nerve injury has been reported however, is a rare complication that normally resolves within 6-8 weeks after the surgery. You will also have some pain after the surgery, which generally improves within a few weeks. 

What happens after I get Inspire®?

You will be scheduled to see the ENT surgeon for follow-up after the surgery. An appointment with the sleep specialist will also be scheduled about 2 months after the procedure.  During this appointment (called the activation visit), tongue movement will be assessed, and the device will be turned ON for the first time.  You will be instructed on how to use the remote control and how to adjust the stimulation.  When the implant is on, it will stimulate the hypoglossal nerve with EVERY breath and not just when there is airway collapse. 

The goal is to get acclimated with the therapy for the next few weeks to months. You will be instructed to use your device Inspire® all night, every night.   You will also be taught on how to increase or decrease the stimulation.  If you are having difficulties with the therapy, make sure you let your sleep specialist know so adjustments can be made to your setting.

Once you are doing well with the therapy (by using it all night, every night), you will need a sleep study in the sleep laboratory to determine the optimal setting that will control your sleep apnea. 

Can I get an X-ray, CT or MRI if I have the implant?

The newer model (3028) is compatible with an MRI scan after special precautions have been taken; however, the older model (3024) is not. All models are compatible with an x-ray and CT scan machine. 

If you want more information on Inspire®, visit https://www.inspiresleep.com.

Oral appliances are devices that can be used to treat some people who have mild or moderate Obstructive Sleep Apnea (OSA) and snoring. There are different types of oral appliances. Common ones include: Mandibular Advancement Devices (MAD), Mandibular Advancement Splints (MAS), Mandibular Repositioning Appliances (MRA), or Tongue Retaining Devices (TRD).

How do oral appliances work?
Oral appliances work by pushing or pulling your lower jaw forward. By doing this, your tongue is kept in a position that does not block your airway. This reduces the risk of snoring or that your tongue may obstruct your airway during sleep. If this device is helping you, the sound of snoring should be gone entirely or lessened.

How effective are oral appliances?
As with all treatments, not everyone gets the same benefit from oral appliances. For some, the OSA and snoring go away completely, while for other people, other forms of treatment are needed. Oral appliances are more likely to work if you have mild or moderate sleep apnea; more recent evidence supports use for some people with severe sleep apnea as well. If your sleep apnea gets better when you lie on your side (compared to sleeping on your back) and if you are not overweight, you are also more likely to benefit from this appliance. If you have central sleep apnea (a less common condition than OSA), then oral appliances are unlikely to be helpful. Until you have been properly fitted for an oral appliance and tried it, no one can know how well it will work for you.

How well do oral appliances work compared to CPAP?
CPAP (Continuous Positive Airway Pressure) is a reliable treatment for sleep apnea. Immediate results are typically seen with CPAP regardless of how bad the sleep apnea is. An oral appliance will usually improve your sleep apnea, but may not completely control it. If you have moderate or severe OSA, CPAP is more likely to work to correct your sleep apnea than an oral appliance. However, an oral appliance may be a better option than no treatment at all if you cannot tolerate CPAP. Oral appliances are also not the main therapy if you have significant heart disease or are very sleepy during the day. In these cases, CPAP is the best treatment. A sleep specialist can provide guidance regarding the most appropriate therapy for you. For more information see the ATS Patient information series piece on “Continuous Positive Airway Pressure for Adults with Obstructive Sleep Apnea” at www.thoracic.org/patients.

Are there any side effects from using oral appliances?
If fitted well, the oral appliance should be comfortable during the night. However, because it acts to push your jaw forward, some people feel discomfort when first using the appliance. This discomfort tends to improve as you use it more. If discomfort happens, it is usually in the joint at the back of your jaw, just in front of the ear (the temporomandibular joint). This discomfort should go away when you take the appliance out in the morning. Also, oral appliances may cause increased saliva in your mouth, or make your teeth feel tender. These symptoms usually settle down quickly the more you use the device. Over time, there may be tooth movement, changes in your bite, or problems with the joint and muscles of your jaw. It is important to have regular follow-up visits with the dentist who supplied you with the appliance to detect and manage problems early.

How can I get an oral appliance?
Your healthcare provider can refer you to a sleep specialist in order to find out how bad your sleep apnea is. This evaluation usually requires an overnight sleep study and a separate follow-up appointment with your sleep specialist to talk about the results and discuss possible treatment options. If you decide to try an oral appliance, your sleep specialist will refer you to a dentist who has extensive training in the treatment of OSA. For more information about sleep studies see ATS Patient Information Series “Sleep Studies in the Sleep Laboratory and at Home” at www.thoracic.org/patients.

Does the appliance need to be specially fitted for me?
Each person has a different mouth and jaw shape, so you should have the oral appliance made to fit you. Your dentist will take an impression of your teeth and send the dental impression (dental mold) to the lab for the appliance to be made. After a few weeks, you will go back to the dentist’s office, where the appliance is fitted into your mouth. It will be adjusted so that it moves your jaw forward to a position that will be effective but is still comfortable. Your dentist will help supervise the adjustment of the device over several weeks. After the appliance is fitted, follow-up visits with your dentist or sleep specialist will be needed.
There are some kinds of dental devices that you can buy over-the-counter (without a prescription). These devices are cheaper, but they usually do not work. They may take up lots of space in your mouth, pushing your tongue toward the throat and making your OSA worse. Getting the proper fitting device is important in helping your sleep problem.

How should I care for my oral appliance?
You should brush and floss your teeth before you put your appliance in each night. Your dentist can prescribe fluoride gel to help prevent tooth decay while using your appliance. Plaque can also build up on an appliance. You must therefore clean it daily. Make sure you dry it out each day before using it again. Also, keep your appliance safely away from children and pets.

How do I know if oral appliance is working?
When an oral appliance is working well, there should be no snoring. If you are wearing the appliance because of sleep apnea, you may see improved sleepiness, fatigue and other symptoms of sleep apnea. A good way to find out if you are getting the help you need from your oral appliance is to have a repeat overnight sleep study with the oral appliance in place. If the study shows that wearing the oral appliance has helped your OSA, you should continue to use if every night. If it is not helping your sleep apnea, other treatments (such as CPAP) will be recommended.

What do I do if my oral appliance does not seem to be working well?
If symptoms of snoring or sleep apnea return (for example, feeling tired during the day), it is important to have a follow up appointment with your dentist or your sleep specialist. Your dentist might need to adjust the appliance. After a number of years, some people using an oral appliance find they need to consider other treatments for their OSA, especially if they have had weight gain.

Action Steps.

Oral appliances may be more convenient than other forms of therapy, but make certain if you use one, it is fitted properly and corrects your sleeping issues.

• Speak with a sleep specialist to find out if an oral appliance may help you.
• If your appliance is not making your symptoms better, report back to your specialist.
• Keep follow-up appointments with your sleep specialist &/or dentist.
• Clean your appliance daily.

Additional Resources:
American Academy of Sleep Medicine
American Sleep Apnea Association
Sleep Health Foundation (Australia)
 

Receive supplemental support for Cognitive Behavioral Therapy for Insomnia (CBT-i) and learn strategies to improve sleep: CBT-i Coach | VA Mobile  

Access a guided weekly training plan, an interactive sleep diary, and other tools to help track and improve sleep: Insomnia Coach | VA Mobile

Watch this video to learn strategies and techniques to help you get comfortable with your PAP unit if you having difficulty with adjustment: Desensitization - YouTube 

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