Disclaimer: None of the information in this article constitutes medical advice, and is just the opinion of the writer(s) and presented for informational purposes only. We recommend that patients follow their doctor’s guidance in regard to medical devices and sleep apnea.
Inspire is a brand which manufactures the only Food and Drug Administration (FDA)-approved device for treating obstructive sleep apnea. The company claims that their device is a more convenient alternative to Continuous Positive Airway Pressure (CPAP) machines.
In this article we’ll review the medical research backing the Inspire device, highlight the side effects, and explain whether we believe it’s truly superior to a CPAP for patients with sleep apnea.
Does Inspire Really Work?
Inspire has funded several clinical trials published in legitimate medical journals which tested the efficacy of their device.
The first medical study, published in a leading Otolaryngology journal in 2018, tracked the results of the Inspire device in 126 patients over 5 years. The researchers found that the device caused improvements in sleep apnea metrics such as snoring and daytime sleepiness, as well as self-reported improvements in quality-of-life metrics.
These results are relatively weak in our opinion, because the study was not placebo-controlled or even compared to other sleep apnea treatments like the CPAP. It does suggest that the Inspire device is better than nothing, but the more clinically-relevant question is whether the Inspire device is superior to CPAP.
A more recent medical trial on the Inspire device reported similar results to the previous trial. Patients using the Inspire device reported fewer sleep apnea events, lower daytime sleepiness scores, and improve quality of life.
The article’s footnotes detail that many of the study authors received grants, fees and paid travel expenses, among other forms of compensation, for their work on this trial. This adds bias to the process and makes the study results weaker in our opinion.
Overall we would conclude from the available research that the Inspire device is likely to be effective. Even though we don’t find either of the studies the company funded to be particularly well designed, and there are conflicts of interest, it does seem clear that this device is significantly superior to taking no action on treating sleep apnea.
Sleep apnea is a serious condition which is highly associated with increased mortality and a variety of chronic diseases, so the more innovation in this field, the better for patients.
How Does Inspire Work?
The innovation of the Inspire device involves a technology called hypoglossal nerve stimulation therapy. An implanted medical device sends electrical signals that prevent the tongue from blocking the airway during sleep, which is a common cause of sleep apnea.
Because we aren’t consciously in control of our tongues during sleep, there is no way to achieve this naturally.
The Inspire device implementation is an outpatient surgery that requires a doctor to cut several small incisions into the patient's skin to insert the device. One incision goes below the collarbone to implant the device. Another goes under the chin where the electrical stimulation is targeted. Inspire notes that some patients require an additional incision on their rib cage.
Inspire Vs. CPAP
Because the Inspire device and CPAP machines are both proven to be effective for treating sleep apnea, many patients are curious about which is more effective.
Unfortunately, there don’t appear to be any medical studies directly comparing the two treatments for a population of patients with sleep apnea.
The CPAP is more well-studied than the Inspire, but medical data suggests it may not be as effective for mild-to-moderate sleep apnea as it is for severe sleep apnea. There are also compliance issues. Because it can be frustrating to use a large face mask at night during sleep, many patients who are prescribed a CPAP don’t use it regularly.
An extensive medical review on CPAP adherence found that over 1 in 3 patients don’t use the device regularly.
Because the causes of sleep apnea are so individualized, we strongly recommend that patients speak with their doctor to determine what the best approach for their unique situation is. There are many different types of CPAP devices, and there doesn’t seem to be clinical evidence suggesting which type is superior or whether the Inspire is superior to the CPAP, so these types of determinations are best left to a medical professional who understands the patient’s history and unique biology.
Misleading Patient Outcomes Section
Inspire has a section of their website highlighting patient outcomes. One of the key figures states that “94% of Inspire patients say Inspire is better than CPAP & would recommend Inspire to others.”
Their citation for this claim is a medical review of patients who used Inspire after a documented intolerance to CPAP.
We find the claim on Inspire’s site to be extremely misleading and unethical, given that their citation is from a self-selected group of people who already had negative experiences with CPAP devices.
Inspire’s claim makes it seem as though both CPAP and Inspire were trialed by a group of neutral patients who hadn’t used either device, and the vast majority of them preferred the Inspire, which simply isn’t the case.
It’s also worth noting that most of the medical research on sleep apnea seems to suggest hypoglossal nerve stimulation devices like Inspire as an alternative treatment when CPAP intolerance is noted, and not a first-line treatment for sleep apnea.
Inspire Side Effects
The medical review from the previous section documented adverse events to Inspire. Only 2% of patients experienced an adverse event during the implementation procedure, which is a relatively low number.
After the operation and during normal use, 23% of patients experienced adverse events, with the most common being “stimulation-related discomfort.” None of the side effects were severe or life-threatening.
We consider this side effect profile to be similar to that experienced by CPAP patients. Around 30% of CPAP patients have been documented in a medical review to experience minor side effects such as a blocked nose, discomforting mask pressure and skin irritation.