A randomized controlled trial to evaluate the efficacy of electrical vestibular nerve stimulation (VeNS), compared to a sham control for the management of sleep in young adults

Sai Sailesh Kumar Goothy; Rajagopalan Vijayaraghavan; Hirok Chakraborty

doi:10.1515/jbcpp-2023-0036

Article

A randomized controlled trial to evaluate the efficacy of electrical vestibular nerve stimulation (VeNS), compared to a sham control for the management of sleep in young adults

Sai Sailesh Kumar Goothy , Rajagopalan Vijayaraghavan and Hirok Chakraborty

Published/Copyright: April 6, 2023

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From the journal Journal of Basic and Clinical Physiology and Pharmacology Volume 34 Issue 3

Abstract

Objectives

Preliminary research suggests that electrical vestibular nerve stimulation (VeNS) may improve sleep outcomes by influencing the hypothalamus and brainstem nuclei involved in regulating the circadian rhythm and wakefulness. This randomised, sham-controlled trial aimed to assess the effectiveness of VeNS on insomnia in young adults.

Methods

Eighty adults aged 18–24 years were randomly allocated to the intervention (n=40) and control groups (n=40). The intervention group was provided with 30 min per day of VeNS with five sessions weekly for four weeks, while the control group received sham stimulation for the same period. Baseline Insomnia Sleep Index (ISI) scores were recorded weekly. At baseline and at day 28, questionnaires to evaluate emotional states of depression, anxiety and stress, and quality of life (QoL) were completed. The primary outcome was change in ISI with comparison between baseline and day 28.

Results

The VeNS group significantly reduced their mean ISI score after 7 days usage (p<0.001). At day 28 it was found that mean ISI scores had reduced from 19 to 11 in the VeNS group, and from 19 to 18 in the sham group, and the difference between the groups was significant (p<0.001). Moreover, application of VeNS appeared to significantly improve emotional state and QoL outcomes.

Conclusions

This trial demonstrates that regular VeNS usage over four weeks leads to a clinically meaningful decrease in ISI scores in young adults with insomnia. VeNS may have potential as a drug-free and non-invasive therapy to improve sleep outcomes by positively influencing the hypothalamic and brainstem nuclei.

Keywords: electrical vestibular nerve stimulation; insomnia; quality of life; sleep; stress

Corresponding author: Sai Sailesh Kumar Goothy, Department of Physiology, Sri Madhusudan Sai Institute of Medical Sciences and Research, Muddenahalli, Karnataka 562101, India, E-mail: sai@vestibularlabs.com

Funding source: Neurovalens, Belfast, UK

Acknowledgments

We gratefully acknowledge the contributions of participants of the study. Special thanks to DR. H. M. Mangal, Dean of R.D Gardi Medical for his support throughout the study.

Research funding: The study was funded by Neurovalens, Belfast, UK. Neurovalens provided the devices which were returned at the end of the study.
Author contributions: All authors have contributed equally, and all authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: The authors state no conflict of interest.
Informed consent: Written informed consent was obtained from all individuals included in this study.
Ethical approval: The research related to human use has complied with all the relevant national regulations, institutional polices, and in accordance with the tenets of the Helsinki Declaration. The study protocol was approved by the institutional human ethical committee of R.D. Gardi Medical College, Ujjain, Madhya Pradesh, India (IEC Ref no-123/2019).

References

1. Chattu, VK, Manzar, MD, Kumary, S, Burman, D, Spence, DW, Pandi-Perumal, SR. The global problem of insufficient sleep and its serious public health implications. Healthcare (Basel) 2018;7:1. https://doi.org/10.3390/healthcare7010001.Search in Google Scholar PubMed PubMed Central

2. Morin, CM, Drake, CL, Harvey, AG, Krystal, AD, Manber, R, Riemann, D, et al.. Insomnia disorder. Nat Rev Dis Prim 2015;1:15026. https://doi.org/10.1038/nrdp.2015.26.Search in Google Scholar PubMed

3. Dopheide, JA. Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Am J Manag Care 2020;26(4 Suppl):S76–S84. https://doi.org/10.37765/ajmc.2020.42769.Search in Google Scholar PubMed

4. de Zambotti, M, Goldstone, A, Colrain, IM, Baker, FC. Insomnia disorder in adolescence: diagnosis, impact, and treatment. Sleep Med Rev 2018;39:12–24. https://doi.org/10.1016/j.smrv.2017.06.009.Search in Google Scholar PubMed PubMed Central

5. Hershner, SD, Chervin, RD. Causes and consequences of sleepiness among college students. Nat Sci Sleep 2014;6:73–84. https://doi.org/10.2147/NSS.S62907.Search in Google Scholar PubMed PubMed Central

6. Riemann, D, Baglioni, C, Bassetti, C, Bjorvatn, B, Dolenc Groselj, L, Ellis, JG, et al.. European guideline for the diagnosis and treatment of insomnia. J Sleep Res 2017;26:675–700. https://doi.org/10.1111/jsr.12594.Search in Google Scholar PubMed

7. De Crescenzo, F, D’Alò, GL, Ostinelli, EG, Ciabattini, M, Di Franco, V, Watanabe, N, et al.. Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis. Lancet 2022;400:170–84. https://doi.org/10.1016/S0140-6736(22)00878-9.Search in Google Scholar PubMed

8. Roth, T, Mayleben, D, Feldman, N, Lankford, A, Grant, T, Nofzinger, E. A novel forehead temperature-regulating device for insomnia: a randomized clinical trial. Sleep 2018;41:zsy045. https://doi.org/10.1093/sleep/zsy045.Search in Google Scholar PubMed PubMed Central

9. Krystal, AD, Zammit, GK, Wyatt, JK, Quan, SF, Edinger, JD, White, DP, et al.. The effect of vestibular stimulation in a four-hour sleep phase advance model of transient insomnia. J Clin Sleep Med 2010;6:315–21. https://doi.org/10.5664/jcsm.27871.Search in Google Scholar

10. Reichenbach, A, Bresciani, JP, Bülthoff, HH, Thielscher, A. Reaching with the sixth sense: vestibular contributions to voluntary motor control in the human right parietal cortex. Neuroimage 2016;124:869–75. https://doi.org/10.1016/j.neuroimage.2015.09.043.Search in Google Scholar PubMed

11. Besnard, S, Tighilet, B, Chabbert, C, Hitier, M, Toulouse, J, Le Gall, A, et al.. The balance of sleep: role of the vestibular sensory system. Sleep Med Rev 2018;42:220–8. https://doi.org/10.1016/j.smrv.2018.09.001.Search in Google Scholar PubMed

12. van Sluijs, RM, Rondei, QJ, Schluep, D, Jäger, L, Riener, R, Achermann, P, et al.. Effect of rocking movements on afternoon sleep. Front Neurosci 2020;13:1446. https://doi.org/10.3389/fnins.2019.01446.Search in Google Scholar PubMed PubMed Central

13. Kumar, SS, Archana, R, Mukkadan, BK. Controlled vestibular stimulation: a physiological method of stress relief. J Clin Diagn Res 2014;8:BM01–2. https://doi.org/10.7860/JCDR/2014/10312.5298.Search in Google Scholar PubMed PubMed Central

14. Martin, T, Moussay, S, Bulla, I, Bulla, J, Toupet, M, Etard, O, et al.. Exploration of circadian rhythms in patients with bilateral vestibular loss. PLoS One 2016;11:e0155067. https://doi.org/10.1371/journal.pone.0155067.Search in Google Scholar PubMed PubMed Central

15. Waselus, M, Valentino, RJ, Van Bockstaele, EJ. Collateralized dorsal raphe nucleus projections: a mechanism for the integration of diverse functions during stress. J Chem Neuroanat 2011;41:266–80. https://doi.org/10.1016/j.jchemneu.2011.05.011.Search in Google Scholar PubMed PubMed Central

16. Rajagopalan, A, Jinu, KV, Sailesh, KS, Mishra, S, Reddy, UK, Mukkadan, JK. Understanding the links between vestibular and limbic systems regulating emotions. J Nat Sci Biol Med 2017;8:11–5. https://doi.org/10.4103/0976-9668.198350.Search in Google Scholar PubMed PubMed Central

17. Bayer, L, Constantinescu, I, Perrig, S, Vienne, J, Vidal, PP, Muhlethaler, M, et al.. Rocking synchronizes brain waves during a short nap. Curr Biol 2011;21:R461–2. https://doi.org/10.1016/j.cub.2011.05.012.Search in Google Scholar PubMed

18. Omitz, EM, Forsythe, AB, DeLaPena, A. The effect of vestibular and auditory stimulation on the rapid eye movements of REM sleep in normal children. Electroencephalogr Clin Neurophysiol 1973;34:379–90. https://doi.org/10.1016/0013-4694(73)90089-8.Search in Google Scholar PubMed

19. Melvill Jones, G, Sugie, N. Vestibulo-ocular responses in man during sleep. Electroencephalogr Clin Neurophysiol 1972;32:43–53. https://doi.org/10.1016/0013-4694(72)90226-X.Search in Google Scholar PubMed

20. Tauber, ES, Handelsman, G, Handelsman, R, Weitzman, E. Vestibular stimulation during sleep in young adults. Arch Neurol 1972;27:221–7. https://doi.org/10.1001/archneur.1972.00490150029006.Search in Google Scholar PubMed

21. Woodward, S, Tauber, ES, Spielmann, AJ, Thorpy, MJ. Effects of otolithic vestibular stimulation on sleep. Sleep 1990;13:533–7. https://doi.org/10.1093/sleep/13.6.533.Search in Google Scholar PubMed

22. van Sluijs, RM, Rondei, QJ, Schluep, D, Jäger, L, Riener, R, Achermann, P, et al.. Effect of rocking movements of afternoon sleep. Front Neurosci 2020;13:1446. https://doi.org/10.3389/fnins.2019.01446.Search in Google Scholar PubMed PubMed Central

23. Goothy, SSK, McKeown, J. Modulation of sleep using electrical vestibular nerve stimulation prior to sleep onset: a pilot study. J Basic Clin Physiol Pharmacol 2020;32:19–23. https://doi.org/10.1515/jbcpp-2020-0019.Search in Google Scholar PubMed

24. Bastien, CH, Vallières, A, Morin, CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med 2001;2:297–307. https://doi.org/10.1016/s1389-9457(00)00065-4.Search in Google Scholar PubMed

25. World Health Organisation. Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL group. Psychol Med 1998;28:551–8. https://doi.org/10.1017/s0033291798006667.Search in Google Scholar PubMed

26. Yang, M, Morin, CM, Schaefer, K, Wallenstein, GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin 2009;25:2487–94. https://doi.org/10.1185/03007990903167415.Search in Google Scholar PubMed

27. Lovibond, SH, Lovibond, PF. Manual for the depression anxiety stress scales, 2nd ed. Sydney: Psychology Foundation of Australia; 1995.10.1037/t01004-000Search in Google Scholar

28. Morin, CM, Belleville, G, Bélanger, L, Ivers, H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 2011;34:601–8. https://doi.org/10.1093/sleep/34.5.601.Search in Google Scholar PubMed PubMed Central

29. Corsi, N, Colloca, L. Placebo and Nocebo effects: the advantage of measuring expectations and psychological factors. Front Psychol 2017;8:308. https://doi.org/10.3389/fpsyg.2017.00308.Search in Google Scholar PubMed PubMed Central

30. Socher, DD, Socher, JA, Azzi, VJB. Evaluation of quality of life pre- and post-vestibular rehabilitation in patients with benign paroxysmal positional vertigo associated with Meniere’s disease. Int Arch Otorhinolaryngol 2012;16:430–6. https://doi.org/10.7162/S1809-97772012000400002.Search in Google Scholar PubMed PubMed Central

31. Joseph, M, Archana, R, Sai Sailesh, K, Mukkadan, JK. A comparative study on effect of vestibular and auditory stimulation on autonomic measures, sleep quality and quality of life in college students. Int J Pharm Biol Sci 2016;7:783–8. https://doi.org/10.22376/ijpbs.2016.7.4.b783-788.Search in Google Scholar

32. Kumar, SS, Rajagopalan, A, Mukkadan, JK. Vestibular stimulation for stress management in students. J Clin Diagn Res 2016;10:CC27–31. https://doi.org/10.7860/JCDR/2016/17607.7299.Search in Google Scholar PubMed PubMed Central

33. Guinand, N, van de Berg, R, Ranieri, M, Cavuscens, S, DiGiovanna, J, Nguyen, TA, et al.. Vestibular implants: hope for improving the quality of life of patients with bilateral vestibular loss. Annu Int Conf IEEE Eng Med Biol Soc 2015;2015:7192–5. https://doi.org/10.1109/EMBC.2015.7320051.Search in Google Scholar PubMed

34. Rajagopalan, A, Kumar, SS, Mukkadan, JK. Effect of vestibular stimulation on auditory and visual reaction time in relation to stress. J Adv Pharm Technol Res 2017;8:34–8. https://doi.org/10.4103/2231-4040.197390.Search in Google Scholar PubMed PubMed Central

35. Parashar, A, Pattnaik, M, Mohanty, P, Swami Vivekanand National Institute of Rehabilitation Training and Research, Olatpur, Bairoi, Cuttack, India. Effect of vestibular stimulation versus whole body vibration on standing balance in children with spastic diplegic cerebral palsy. J Nov Physiother 7:348. https://doi.org/10.4172/2165-7025.1000348.Search in Google Scholar

36. Devi, N, Mukkadan, JK. Impact of rotatory vestibular stimulation and curcuma longa on spatial learning and memory in wistar albino rats. Asian J Pharmaceut Clin Res 2016;9:167–73.Search in Google Scholar

37. Serrador, JM, Schlegel, TT, Black, FO, Wood, SJ. Vestibular effects on cerebral blood flow. BMC Neurosci 2009;10:119. https://doi.org/10.1186/1471-2202-10-119.Search in Google Scholar PubMed PubMed Central

38. Shin, JH, Kim, YK, Kim, HJ, Kim, JS. Altered brain metabolism in vestibular migraine: comparison of interictal and ictal findings. Cephalalgia 2014;34:58–67. https://doi.org/10.1177/0333102413498940.Search in Google Scholar PubMed

Received: 2023-02-08

Accepted: 2023-03-14

Published Online: 2023-04-06

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Articles in the same Issue

https://doi.org/10.1515/jbcpp-2023-0036

Keywords for this article

electrical vestibular nerve stimulation; insomnia; quality of life; sleep; stress