Bioelectronic Medicine (Aug 2023)

Obstructive sleep apnea improves with non-invasive hypoglossal nerve stimulation using temporal interference

  • Florian Missey,
  • Malin Silverå Ejneby,
  • Ibrahima Ngom,
  • Mary J. Donahue,
  • Jan Trajlinek,
  • Emma Acerbo,
  • Boris Botzanowski,
  • Antonino M. Cassarà,
  • Esra Neufeld,
  • Eric D. Glowacki,
  • Lee Shangold,
  • William M. Hanes,
  • Adam Williamson

DOI
https://doi.org/10.1186/s42234-023-00120-7
Journal volume & issue
Vol. 9, no. 1
pp. 1 – 12

Abstract

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Abstract Background Peripheral nerve stimulation is used in both clinical and fundamental research for therapy and exploration. At present, non-invasive peripheral nerve stimulation still lacks the penetration depth to reach deep nerve targets and the stimulation focality to offer selectivity. It is therefore rarely employed as the primary selected nerve stimulation method. We have previously demonstrated that a new stimulation technique, temporal interference stimulation, can overcome depth and focality issues. Methods Here, we implement a novel form of temporal interference, bilateral temporal interference stimulation, for bilateral hypoglossal nerve stimulation in rodents and humans. Pairs of electrodes are placed alongside both hypoglossal nerves to stimulate them synchronously and thus decrease the stimulation amplitude required to activate hypoglossal-nerve-controlled tongue movement. Results Comparing bilateral temporal interference stimulation with unilateral temporal interference stimulation, we show that it can elicit the same behavioral and electrophysiological responses at a reduced stimulation amplitude. Traditional transcutaneous stimulation evokes no response with equivalent amplitudes of stimulation. Conclusions During first-in-man studies, temporal interference stimulation was found to be well-tolerated, and to clinically reduce apnea-hypopnea events in a subgroup of female patients with obstructive sleep apnea. These results suggest a high clinical potential for the use of temporal interference in the treatment of obstructive sleep apnea and other diseases as a safe, effective, and patient-friendly approach. Trial registration The protocol was conducted with the agreement of the International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States Code of Federal Regulations (CFR) and followed the approved BRANY IRB File # 22-02-636-1279.

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