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Inspire Hypoglossal Nerve Stimulator Implantation
The hypoglossal nerve comes off the base of the brain, travels through the bottom of the skull, passes through the upper neck and to the tongue. It is the nerve that is responsible for tongue motion. There is another nerve, the lingual nerve, that gives the tongue sensation and taste; it is not used during the implantation of the stimulator.
What is Inspire Hypoglossal Nerve Stimulator Implant?
Inspire therapy is a mask-free solution for people with obstructive sleep apnea (OSA), who have tried and struggled with CPAP. Patients must have moderate to severe OSA and not tolerate the positive airway pressure therapy.
It has three components:
- A programmable neuro-stimulator, “pulse generator,” that is placed in a pocket under the skin on the pectoralis (chest) muscle.
- Stimulator lead that delivers mild stimulation to the tongue nerve from the pulse generator, moving the tongue forward to the front of your mouth and stiffening the palate to allow for better breathing.
- A pressure-sensing lead placed between the ribs that detects inspiration and triggers the hypoglossal nerve stimulation.
These are activated with a handheld remote control and monitored with a smart phone app.
Inspire Nerve Stimulator Eligibility Requirements
The Inspire therapy device isn’t recommended for everyone with sleep apnea. There are specific requirements patients must meet before an Inspire implant can be placed:
- Be over the age of 18
- Have an OSA diagnosis with an AHI score between 15 and 100 (moderate to severe). Mild obstructive sleep apnea does not qualify for implantation.
- Have already tried CPAP therapy, with it either being unsuccessful or unbearable to use.
- Have a body mass index less that 40 (varies with insurance provider).
- Have a Drug Induced Sleep Endoscopy (DISE). This is a nonsurgical exam, during which a camera is used to evaluate the pattern of obstruction in the throat while the patient is sedated. This is a separate procedure from the actual Inspire implantation.
- Patients cannot have a diagnosis that contains more than 25% central or mixed sleep apnea (seen on a sleep study), or a complete concentric collapse of the soft palate seen
during the DISE procedure. - No significant comorbidities (neuromuscular disease, hypoglossal nerve palsy, severe cardiopulmonary disease, active psychiatric disease).
- No pronounced upper airway anatomic abnormalities (for example, grade 3 to 4 tonsils).
Inspire Hypoglossal Nerve Stimulator Implantation Process
The drug induces sleep endoscopy (DISE) must be done before the actual stimulator implantation, usually in a separate procedure. The patient is brought into the operating room and sedated. As they fall asleep, a small, flexible scope is placed through the nose and the airway is observed while the patient is falling asleep. This is done to look at the pattern of closure/obstruction in the throat.
In order to be eligible for the implantation there cannot be a “circumferential closure” of the throat—I describe this as a “purse-string” type closure. It has to be mostly an anterior-posterior blockage as the soft palate closes against the back wall of the throat. Ninety percent of patients pass this evaluation. The results are then sent to your insurance company for approval. Some insurances allow us to do the DISE and the implantation on the same day.
The implantation process is performed under general anesthesia. Once asleep, the Inspire-surgeon makes two incisions: One below the right side of the chin and the other just below the collar bone. The stimulation lead is placed on the hypoglossal nerve under the chin, and its wire is tunneled under the skin, over the collarbone, and to the stimulator. The breathing sensor is placed between the second and third ribs, using the same incision under the collar bone, where the stimulator is placed. Once the implantation is done, we test the stimulation levels and the respiratory sensors for proper function and adjust the placement as necessary. The incisions are then closed with absorbable sutures and sealed with skin adhesive and tape strips. The typical surgery takes 1-1/2 to 2-1/2 hours.
Risks of Implantation
As with any surgery, there are risks. These are typically minor and resolve on their own.
- Infection is a serious risk associated with this procedure and may require removal of the deviced.
- Bleeding or blood vessel damage. A collection of blood, called a hematoma, may need to be drained.
- Nerve damage (weakness or numbness of the tongue).
- Allergy to the implant, rare.
- Scar tissue forming around the implant, which can make it difficult to remove the implant in the future.
- Persistent pain, numbness or inflammation at the surgery sites.
- Migration (movement) of the pulse generator or breathing sensor.
- Pneumothorax (air that enters the chest cavity and collapses a lung) needing treatment from a surgeon.
- Sensation of tethering or pulling from the electrode wire in the neck.
- Malfunction of the device or components that may necessitate surgery for replacement.
- Pleural effusion (fluid accumulating around the lung) needing drainage.
- Risks of general anesthesia, that are increased in people with obstructive sleep apnea.
Anticipated Results
After a successful Inspire stimulator implantation, typical results include a significant reduction in sleep apnea events (often around 70 80% decrease), marked improvement in snoring severity, and noticeable reduction in daytime sleepiness, with most patients experiencing a significant improvement in their sleep quality overall; this is usually accompanied by a lowered apnea- hypopnea index (AHI) score and better quality of life.
Key points about successful Inspire results:
Reduced sleep apnea events
Studies show a substantial decrease in the number of sleep apnea events per hour after Inspire implantation.
Improved sleep quality
Due to less sleep apnea and snoring, patients often report better overall sleep quality and less daytime fatigue.
Positive impact on daily function
Improved sleep quality can lead to better concentration, mood, and overall daily functioning.
Snoring reduction
Most patients experience a significant reduction in snoring intensity and severity.
AHI improvement
A significant drop in the apnea-hypopnea index (AHI) score is typically observed after Inspire treatment. This means improvement in sleep apnea.
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