Electrical stimulation may reduce OSA severity in patients with low CPAP adherence
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Key takeaways:
- Domiciliary transcutaneous electrical stimulation may be a suitable OSA treatment option for patients who have low CPAP adherence.
- These patients saw improvement in disease severity and sleepiness.
In patients with obstructive sleep apnea and poor CPAP adherence, domiciliary transcutaneous electrical stimulation for 3 months improved disease severity compared with CPAP, according to results published in eClinicalMedicine.
“We have excellent and evidence-based treatment for patients with obstructive sleep apnea using CPAP therapy or mandibular advancement devices,” Joerg Steier, MD, PhD, professor of respiratory and sleep medicine at King’s College London and consultant at Guy’s & St. Thomas’ NHS Foundation Trust, told Healio. “However, we now understand that not one therapy suits every patient, and we also know that many patients do not continue with CPAP therapy in the long term. This study provides evidence that a relatively new method, hypoglossal nerve stimulation, may not only be delivered via an implantable device, but could in the future possibly be provided for many patients noninvasively as well.”
In a single-center, open-label, randomized controlled phase 3 trial, Steier and colleagues evaluated 56 patients with OSA who used CPAP for less than 4 hours per night and had a BMI between 18.5 kg/m2 to 32 kg/m2 to see how domiciliary transcutaneous electrical stimulation (TESLA) device (EMS Premier Combo Plus, Everyway Medical Instruments Co. Ltd.) usage for 3 months impacted OSA severity, measured via the apnea-hypopnea index (AHI), and if it was safe compared with usual care (CPAP).
Researchers also assessed 4% oxygen desaturation index (ODI), sleepiness and therapy compliance.
Notably, with enrollment taking place from June 2018 to February 2023, the COVID-19 pandemic impacted study recruitment, follow-up visits and polysomnography, which switched from an inpatient test to a home-based test.
Of the total cohort, 29 patients (median, 55.8 years; 19 men; median BMI, 28.7 kg/m2) received domiciliary TESLA, and the remaining 27 patients (median age, 59.3 years; 18 men; median BMI, 28.4 kg/m2) received CPAP.
OSA severity, sleepiness, compliance
Median AHI at baseline was higher among those in the domiciliary TESLA group compared with the CPAP group (24 events per hour vs. 14.4 events per hour).
Before adjusting for the baseline value, researchers found a significant group difference in AHI at 3 months between patients receiving domiciliary TESLA (–8.2 events per hour; 95% CI, –13.4 to –3) and patients receiving CPAP (+3.3 events per hour; 95% CI, –4.7 to 11.3), for a significant mean group difference of –11.5 events per hour (95% CI, –20.7 to –2.3; P = .016).
However, this difference lost significance following adjustment for the baseline value, although it did favor domiciliary TESLA (–7 events per hour; 95% CI, –15.7 to 1.8), according to researchers.
In terms of ODI, researchers observed significant mean differences between the groups that favored domiciliary TESLA before adjustment (–11.3; 95% CI, –19.3 to –3.2; P = .007) and after adjustment (–8.3; 95% CI, –16.1 to –0.6; P = .036).
Between-group differences in Epworth Sleepiness Scale scores also favored the treatment group (unadjusted, –3 points; 95% CI, –5.4 to –0.5; P = .019; adjusted, –2.6 points; 95% CI, –4.9 to –0.4; P = .02).
Compared with the CPAP group, who used their therapy for an average of 0 days per week and 0 hours per night, patients in the domiciliary TESLA group demonstrated better compliance with their therapy, with an average use of 4 days a week and 4.5 hours per night (P < .001 for both).
“We were surprised that the intervention arm performed better than usual care, which was CPAP therapy,” Steier told Healio. “However, the control group was, of course, preselected with low adherence. Nonetheless, it underlines that patients who do not get on with first-line therapy may still benefit from second-line therapy, or non-CPAP alternatives.”
Additional findings
Even though patients in the domiciliary TESLA group did see significant improvement in snoring at 3 months (–26.9 minutes; P < .001) compared with baseline, researchers found no significant difference in this measure between the groups.
Further, researchers observed comparable quality-of-life scores for the domiciliary TESLA and CPAP groups based on the Functional Outcome of Sleep Questionnaire, the Euro-Quality of Life five-dimension questionnaire and the VAS.
In terms of adverse events, one patient receiving domiciliary TESLA experienced mild headaches and stopped the therapy early, which resolved the issue.
Additionally, three patients experienced minor skin irritation from the sticky patches of the TESLA device.
“We have developed many ideas and hypotheses while working on this method,” Steier told Healio. “We have observed that electrical stimulation also impacts the cardiovascular system, for example by lowering the blood pressure. We are currently planning several follow-up studies to understand these mechanisms.”
Along with this plan, Steier detailed several other areas for future research.
“We still need to focus on the identification of responders to this treatment, as not everyone benefits to the same degree,” Steier said. “Future studies will also need to look at health economical data to support the case in different health care settings and apply for funding via regular routes — in the U.K. that would be via [National Institute for Health and Care Excellence], and in other health care systems the insurers would need to have these data for approval as well.”
References:
- Alsharifi A, et al. Front Physiol. 2023;doi:10.3389/fphys.2023.1089837.
- TENS machine provides cheaper and non-invasive treatment for sleep apnea. https://www.kcl.ac.uk/news/tens-machine-cheaper-non-invasive-treatment-sleep-apnoea. Published Aug. 3, 2023. Accessed Aug. 3, 2023.
For more information:
Joerg Steier, MD, PhD, can be reached at joerg.steier@gstt.nhs.uk.