Randomised, controlled crossover trial of intermittent and continuous transcutaneous electrical stimulation of the genioglossus muscle for obstructive sleep apnoea

Abstract

PurposeContinuous transcutaneous electrical stimulation (CTES) of the genioglossus muscle may benefit patients with obstructive sleep apnoea (OSA). However, the therapeutic value of intermittent transcutaneous electrical stimulation (ITES) for OSA is unclear.MethodsThis was a randomised, controlled, crossover study to compare the effects of ITES and CTES of the genioglossus muscle. Over three single-night sessions, participants were alternately subjected to three genioglossus stimulation modalities during sleep (sham, CTES and ITES). The apnoea-hypopnoea index (AHI) and oxygen desaturation index (ODI) were used for OSA diagnosis and to evaluate efficacy. A responder was defined as an individual with a ≥50% reduction in AHI together with <10 AHI events per hour and/or an ODI reduction of ≥25% between sham stimulation and electrical stimulation nights.ResultsFifteen men with OSA completed the study. Compared with sham, the median AHI with ITES decreased by 13.3 events/hour (95% CI 3.1 to 23.5, p=0.030) and by 7.3 events/hour (95% CI −3.9 to 18.5, p=0.825) with CTES. The median ODI was reduced by 9.25 events/hour (95% CI 0.5 to 18.0) with ITES and 3.3 events/hour (95% CI −5.6 to 12.2) with CTES; however, there was no significant difference between groups. Furthermore, ITES outperformed CTES with respect to longest apnoea duration (median (95% CI), 9.5 (0.0 to 19.0), p=0.011)) and the highest sleep efficiency (12.2 (2.7 to 21.7), p=0.009). Of the 15 participants, 8 responded to ITES and 3 responded to CTES (p=0.058), of whom all eight cases and two out of three cases had ODIs <5 events/hour, respectively. All participants tolerated ITES well.ConclusionsITES improved upper airway obstruction in patients with OSA, suggesting that further prospective validation of the intermittent approach is warranted.Trial registration numberChiCTR2100050138.

A randomized controlled crossover trial of acute intermittent and continuous hypoxia exposure in mild–moderate obstructive sleep apnea: A feasibility study

“…For each participant receiving another three sleep‐monitoring sessions during the study, a wireless, non‐contact, ultra‐wide band (UWB) radar sleep apnea monitor was used to screen for OSA (Li et al, 2023; Zhao et al, 2021; Zhao et al, 2022). The monitor is described in detail in our previous study (Wu et al, 2022). Briefly, this monitoring system includes a UWB radar monitor (OrbSense, ZG‐S01D) and a MegaRing blood oxygen monitor (ZG‐P11F), both of which were supplied by Megasens Technology (Hangzhou, China).…”

“…The primary outcome was difference in OSA severity between normoxia and hypoxia exposures as determined by AHI and ODI. The primary efficacy outcome was cases responding to ACH or AIH, where a responder was defined as a subject with a ≥ 50% reduction in AHI (Strollo Jr et al, 2014; Wu et al, 2022). The secondary outcomes were reductions in T90 and the incidence and severity of symptoms and AEs related to normoxia and hypoxia exposure.…”

“…The secondary outcomes were reductions in T90 and the incidence and severity of symptoms and AEs related to normoxia and hypoxia exposure. The secondary efficacy outcome was cases with < 10 AHI events per hr and/or an ODI reduction of ≥ 25% between normoxia and hypoxia exposures (Strollo Jr et al, 2014; Wu et al, 2022).…”

“…For each participant receiving another three sleepmonitoring sessions during the study, a wireless, non-contact, ultrawide band (UWB) radar sleep apnea monitor was used to screen for OSA (Li et al, 2023;Zhao et al, 2021;Zhao et al, 2022). The monitor is described in detail in our previous study (Wu et al, 2022).…”

“…Adherence to CPAP appears to be even worse in patients with mild–moderate or asymptomatic OSA (Netzer et al, 2016). To overcome this limitation, non‐CPAP therapies (Randerath et al, 2021; Lorenzi‐Filho et al, 2017; Mediano et al, 2019) such as oral appliance (OA) therapy (Stern et al, 2021), hypoglossal nerve electrical stimulation (HGNS; Baptista et al, 2020; Steier et al, 2011), transcutaneous submental electrical stimulation (Steier et al, 2011; Pengo et al, 2016; Wu et al, 2022) and pharmacological therapies (Gottlieb & Punjabi, 2020; Randerath et al, 2021) are increasingly being explored as alternatives to CPAP. However, there are currently no recommended pharmacological therapies for OSA, and use of HGNS has been limited due to its invasiveness and narrow indications (Gottlieb & Punjabi, 2020).…”