Inspire Hypoglossal Nerve Stimulation device

[Rgn3]

My sleep physician mentioned the Inspire device so I did a search for information about the device. The Inspire system is an implantable nerve stimulator used to treat moderate to severe obstructive sleep apnea in individuals who failed PAP or BPAP. The Inspire system consists of implanted components including the implantable pulse generator (IPG), stimulation lead, and sensing lead and external components. The Inspire device was approved by the  FDA in 2020.
https://www.fda.gov/medical-devices/rece...130008s039
 
The European Respiratory Society recently published a guideline on non-CPAP therapies for obstructive sleep apnea. The report recommendation about the Inspire device:  we suggest that HNS (Hypoglossal Nerve Stimulation) compared to no treatment should be considered as a salvage treatment in patients with symptomatic OSA, who cannot be sufficiently treated with positive airway pressure treatment (CPAP, bilevel positive airway pressure) or MAD (Mandibular Advancement Device), and who have an AHI <50 events·h and a BMI <32 kg·m (conditional recommendation, very low quality of evidence)”.  
So, the Society concluded that the evidence for the Inspire was of very low quality.
https://pubmed.ncbi.nlm.nih.gov/34853097/

My situation: I previously used a mandibular advancement device with limited success and then switch to using  PAP. I was using a nose mask and chin strap and had difficulty with the chin strap. I then tried several face masks but had difficulty with leaking. This is when my physician mentioned the availability of the Inspire device. I subsequently learned about Cover-Role Stretch tape and am using the mouth tape and am doing better with the nasal mask and mouth tape combination.

[Sleeprider]

There are a number of related threads linked below if you scroll down. We have had several members consider Inspire, and results have been mixed. In general, it is suitable for individuals with minor to moderate sleep apnea, and it really targets a specific region in the upper airway that can be stimulated by the hypoglossal nerve. If obstruction is not at the base of the tongue, and resides in the soft palate, or pharynx, it may be less effective. You have shown efficacy with CPAP and have mostly posted results from a FP Icon Auto CPAP several years ago http://www.apneaboard.com/forums/Thread-...chin-strap

Since you are currently using an Airsense 10 Autoset, it might be helpful to see some current results, and to understand better why you are considering a procedure that is very expensive, moderately invasive and potentially not as effective. In your current thread http://www.apneaboard.com/forums/Thread-...-mask-leak it appears you are using a pressure of 5-10 with EPR 3 and are experiencing positional apnea and a high leak rate with your F&P Vitera mask. I will try to be more active in this other thread to make some suggestions. You clearly need bot a soft cervical collar and higher minimum and maximum pressure. I will suggest a minimum pressure of 7.0, maximum pressure 12.0 and maintain EPR 3. A soft cervical collar is indicated by the clusters.

[Rgn3]

   You have shown efficacy with CPAP and have mostly posted results from a FP Icon Auto CPAP several years ago http://www.apneaboard.com/forums/Thread-...chin-strap.  Since you are currently using an Airsense 10 Autoset, it might be helpful to see some current results, and to understand better why you are considering a procedure that is very expensive, moderately invasive and potentially not as effective. 

Thank you for your response. I never considered the Inspire to be a suitable option for me. I hope that the European Respiratory Society guideline will be helpful for those who are considering the Inspire device.
I am travelling now and will post current Oscar with the Airsense 10 Autoset when I return home in several weeks and have access to a SD card computer.

[Sleeprider]

I missed the intent on citing the article. While the linked article discussing several therapies, it did not offer results, only an abstract and conflict of interest statement.

We used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to assess the quality of the evidence and the strength of recommendations. The resulting guideline addresses gastric bypass surgery, custom-made dual-block mandibular advancement devices, hypoglossal nerve stimulation, myofunctional therapy, maxillo-mandibular osteotomy, carbonic anhydrase inhibitors and positional therapy. These recommendations can be used to benchmark quality of care for people with OSA across Europe and to improve outcomes.

Was there an article with the actual findings? This is your link https://pubmed.ncbi.nlm.nih.gov/34853097/

[Rgn3]

Was there an article with the actual findings?  This is your link https://pubmed.ncbi.nlm.nih.gov/34853097/

This is the link to the full guideline article
https://err.ersjournals.com/content/30/162/210200.long

(The link I initially gave gives the  abstract than need to click on the "full text link" at the top right hand side for the complete article).

The article reviews multiple treatments including weight reduction, mandibular advancement devices, hypoglossal nerve stimulation and myofunctional therapy.
Perhaps you and other apneaboard experts could make comments on the complete article. New thread?

[Sleeprider]

Text of relevant section copied below.  As suspected, the efficacy does not justify Inspire or hypoglossal nerve stimulation (HNS) as a first-line therapy, and CPAP seems to achieve better results.  The surgery and inplant are extremely expensive relative to CPAP, so I don't expect to see insurance funding this alternative in most cases.  I could see including this reference in a wiki discussion of Inspire.

PICO 3: should HNS during sleep or no treatment be used for adult patients with OSA?
Conditional recommendation against the intervention, very low quality of evidence.

Summary of the evidence
931 references were identified; three different RCTs were identified [20, 52–55], while three other trials were either terminated or ongoing [56–58] (supplementary figure e3, supplementary tables e6 and e13; no meta-analysis was conducted). Two of the studies included invasive HNS, while one study was on transcutaneous HNS. Inconsistency in the study designs and in the reporting of the results (median/mean) meant that no meta-analysis was performed. The AHI and 4% oxygen desaturation index were assessed using PSG at different follow-up points (range 1 night to 6 months). Two out of three included studies showed no statistical difference between groups at 1 night and 6 months follow-up, while one study showed a statistically significant difference favouring the intervention after 1 week therapy withdrawal in previous responders [20]. Sleep efficiency (percentage of total sleep time) was assessed using PSG (follow-up 1 night) [53]. One study reported sleep efficiency for the 1 night of each intervention and showed no statistically significant difference between arms [53]. None of the studies showed any statistically significant effect for sleepiness. Quality of life was assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ) and Beck Depression Inventory; the follow-up range was 1 week to 6 months. Two studies reported outcomes relating to quality of life (1 week and 6 months follow-up) and both showed statistically significant effects favouring the intervention. One study reported no statistically significant differences between intervention and control looking at systolic and diastolic blood pressure after a week of therapy withdrawal [20]. Compliance/adherence was assessed during follow-up (1 night); only one study reported compliance after the 1 night of treatment [53] (TESLA trial: “The patients’ device acceptance was good with patients reporting no skin discomfort or unpleasant sensations at night. There was no difference in patients’ perceived sleep quality. There was a 59% reduction in mouth dryness after active treatment compared to sham-stimulation. There were no severe adverse events”). Adverse events were reported in two studies narratively. The STAR trial reported two serious adverse device-related events and another 33 serious adverse events that were not device-related [20]. Most nonserious adverse events were implantation-related. The TESLA trial (transcutaneous) reported as the only significant side-effect one patient who complained about claustrophobia at night; this was during both nights (intervention and sham-control). The total count of mild side-effects occurred in 2.8% of the studied cohort and there were no severe adverse events [53].

Task force recommendation
We suggest that HNS should not be used as first-line treatment for OSA patients in general (conditional recommendation, very low quality of evidence). However, we suggest that HNS compared to no treatment should be considered as a salvage treatment in patients with symptomatic OSA, who cannot be sufficiently treated with positive airway pressure treatment (CPAP, bilevel positive airway pressure) or MAD, and who have an AHI <50 events·h−1 and a BMI <32 kg·m−2 (conditional recommendation, very low quality of evidence) (supplementary table e13).

Justification of recommendation
There is limited evidence available for this intervention; a general recommendation was based on selected patients from three RCTs with very strict patient selection (only ∼10% of the screened patients were included) [20, 52, 53]. The recommendation for a salvage therapy is based on the inclusion criteria and results of the STAR trial [20].

Other considerations
Additional confirmation of safety and efficacy is now available on HNS in the follow-up cohorts of trials (⩾5 years). Various methods have become available (HNS, targeted, bilateral, transcutaneous) and particular focus should be on the differentiation into invasive versus transcutaneous (noninvasive) procedures. HNS is currently not applied in many countries; except for the noninvasive approach, it remains costly, and a cost-effectiveness analysis in European healthcare systems will be useful. In the United Kingdom, the National Institute for Health and Care Excellence has published an interventional procedural guidance on safety and efficacy, but reimbursement remains unclear. In other countries, like Germany, the method has become available, but is only available to few patients. In a specific group of patients who do not adequately respond to CPAP or MAD and remain sleepy, this method may be beneficial. However, the invasiveness of HNS means that it is not easily reversible. The transcutaneous method is more affordable and is currently undergoing an RCT in the domiciliary setting (TESLA home) [59].

Regular follow-up should be performed, similar to CPAP and other treatments, to demonstrate efficacy.

Suggestions for future research
The task force recommends further RCTs with CPAP or MAD as control, focused on physiological outcomes, systemic hypertension, metabolic effects and symptomatic improvement.