TY - JOUR
T1 - Domiciliary transcutaneous electrical stimulation in patients with obstructive sleep apnoea and limited adherence to continuous positive airway pressure therapy
T2 - a single-centre, open-label, randomised, controlled phase III trial
AU - Ratneswaran, Deeban
AU - Cheng, Michael
AU - Nasser, Ebrahim
AU - Madula, Rajiv
AU - Pengo, Martino
AU - Hope, Kath
AU - Schwarz, Esther I.
AU - Luo, Yuanming
AU - Kaltsakas, Georgios
AU - Polkey, Michael I.
AU - Moxham, John
AU - Steier, Joerg
N1 - Funding Information:
This study was supported by the United Kingdom Clinical Research Collaboration -registered King's Clinical Trials Unit at King's Health Partners , which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King's College London and the NIHR Evaluation, Trials and Studies Coordinating Centre . Following external peer-review this trial was funded by a pump priming award of the British Lung Foundation (BLF; PPRG17-13 ). We gratefully acknowledge the support of the patients and staff at the Sleep Disorders Centre at Guy’s & St Thomas’ NHS Foundation Trust.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/8
Y1 - 2023/8
N2 - Background: Hypoglossal nerve stimulation (HNS) for obstructive sleep apnoea (OSA) is a novel way to manage the condition. We hypothesised that in patients with OSA and limited adherence to continuous positive airway pressure (CPAP) therapy, domiciliary transcutaneous electrical stimulation (TESLA) would control sleep apnoea and provide health benefits. Methods: We undertook a single-centre, open-label, randomised, controlled phase III trial in patients with OSA (apnoea-hypopnoea-index [AHI] 5–35 h−1), a BMI of 18.5–32 kg∗m−2, and a documented lack of adherence to CPAP therapy (<4 h∗night−1) at Guy's & St Thomas’ NHS Foundation Trust (hospital), UK. Patients were randomly assigned (1:1) using minimisation (gender and OSA severity) to receive TESLA or usual care (CPAP) for at least 3 months; sleep study analysis was provided without knowledge of the assignment arm. The primary outcome was change in AHI at 3-months. The primary outcome and safety were analysed in the intention-to-treat population. Data are reported as median (interquartile range), unless otherwise explained. This trial is registered at ClinicalTrials.gov, NCT03160456. Findings: Between 6 June 2018 and 7 February 2023, 56 participants were enrolled and randomly assigned (29 patients in the intervention group and 27 in the usual care group). Patients were followed up for a median of 3.0 months (IQR 3.0; 10.0). The groups were similar in terms of age (55.8 (48.2; 66.0) vs 59.3 (47.8; 64.4) years), gender (male:female, 19:10 vs 18:9) and BMI (28.7 (26.4; 31.9) vs 28.4 (24.4; 31.9) kg∗m−2). The unadjusted group difference in the ΔAHI was −11.5 (95% CI −20.7; −2.3) h−1 (p = 0.016). Adjusted for the baseline value, the difference was ΔAHI −7.0 (−15.7; 1.8) h−1 (p = 0.12), in favour of the intervention. Minor adverse events were found in one of the participants who developed mild headaches related to the intervention. Interpretation: Domiciliary TESLA can be used safely and effectively in OSA patients with poor adherence to CPAP, with favourable impact on sleepiness and sleep fragmentation. Despite pandemic-related limitations of the amended protocol this trial provides the evidence that TESLA improves clinically meaningful outcomes over the observed follow up period, and the transcutaneous approach is likely to offer an affordable alternative for responders to electrical stimulation in clinical practice. Funding: British Lung Foundation, United Kingdom Clinical Research Collaboration-registered King's Clinical Trials Unit at King's Health Partners.
AB - Background: Hypoglossal nerve stimulation (HNS) for obstructive sleep apnoea (OSA) is a novel way to manage the condition. We hypothesised that in patients with OSA and limited adherence to continuous positive airway pressure (CPAP) therapy, domiciliary transcutaneous electrical stimulation (TESLA) would control sleep apnoea and provide health benefits. Methods: We undertook a single-centre, open-label, randomised, controlled phase III trial in patients with OSA (apnoea-hypopnoea-index [AHI] 5–35 h−1), a BMI of 18.5–32 kg∗m−2, and a documented lack of adherence to CPAP therapy (<4 h∗night−1) at Guy's & St Thomas’ NHS Foundation Trust (hospital), UK. Patients were randomly assigned (1:1) using minimisation (gender and OSA severity) to receive TESLA or usual care (CPAP) for at least 3 months; sleep study analysis was provided without knowledge of the assignment arm. The primary outcome was change in AHI at 3-months. The primary outcome and safety were analysed in the intention-to-treat population. Data are reported as median (interquartile range), unless otherwise explained. This trial is registered at ClinicalTrials.gov, NCT03160456. Findings: Between 6 June 2018 and 7 February 2023, 56 participants were enrolled and randomly assigned (29 patients in the intervention group and 27 in the usual care group). Patients were followed up for a median of 3.0 months (IQR 3.0; 10.0). The groups were similar in terms of age (55.8 (48.2; 66.0) vs 59.3 (47.8; 64.4) years), gender (male:female, 19:10 vs 18:9) and BMI (28.7 (26.4; 31.9) vs 28.4 (24.4; 31.9) kg∗m−2). The unadjusted group difference in the ΔAHI was −11.5 (95% CI −20.7; −2.3) h−1 (p = 0.016). Adjusted for the baseline value, the difference was ΔAHI −7.0 (−15.7; 1.8) h−1 (p = 0.12), in favour of the intervention. Minor adverse events were found in one of the participants who developed mild headaches related to the intervention. Interpretation: Domiciliary TESLA can be used safely and effectively in OSA patients with poor adherence to CPAP, with favourable impact on sleepiness and sleep fragmentation. Despite pandemic-related limitations of the amended protocol this trial provides the evidence that TESLA improves clinically meaningful outcomes over the observed follow up period, and the transcutaneous approach is likely to offer an affordable alternative for responders to electrical stimulation in clinical practice. Funding: British Lung Foundation, United Kingdom Clinical Research Collaboration-registered King's Clinical Trials Unit at King's Health Partners.
KW - CPAP
KW - Genioglossus
KW - Hypoglossal nerve stimulation
KW - Non-CPAP therapy
UR - http://www.scopus.com/inward/record.url?scp=85168533944&partnerID=8YFLogxK
U2 - 10.1016/j.eclinm.2023.102112
DO - 10.1016/j.eclinm.2023.102112
M3 - Article
AN - SCOPUS:85168533944
SN - 2589-5370
VL - 62
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 102112
ER -