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.

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.

Modulation of sleep using electrical vestibular nerve stimulation prior to sleep onset: a pilot study.

OBJECTIVES: Electrical stimulation of the vestibular system (VeNS) has been shown to improve Insomnia Severity Index (ISI) when delivered during sleep. We hypothesize that repeated electrical vestibular stimulation, when delivered prior to sleep onset, will improve ISI scores. The primary aim of this study was to assess the effect that VeNS had on ISI scores when delivered prior to sleep onset. A secondary aim was to provide initial data indicating "length of time to effect" that will allow more appropriate design of a larger randomized control trial (RCT). METHODS: The present study was an experimental study (pre and post without control). The participants acted as self-controls. After recording the baseline values, electrical vestibular nerve stimulation was administered as intervention once in a day for 30 min, 1 h prior to sleep onset using ML1000 device (Neurovalens, UK) for 14 days. RESULTS: There was significant decrease in the ISI scores followed by the electrical vestibular nerve stimulation. Further, participants reported a significant increase in well-rested sleep post the intervention period. CONCLUSIONS: This study supports our hypothesis that VeNS has a positive impact on ISI scores when delivered on a regular basis prior to sleep onset.

Electrical vestibular nerve stimulation as an adjunctive therapy in the management of type 2 diabetes.

OBJECTIVES: Vestibular nerve stimulation using the portable battery-operated vestibular nerve stimulator is a sophisticated method noninvasive, safe, and easy to operate. It was hypothesized that vestibular nerve stimulation is effective in the management of type 2 diabetes. Hence, the present study was undertaken to determine the effectiveness of vestibular nerve stimulation using portable battery-operated vestibular nerve stimulator in the management of diabetes. METHODS: The present study was a double-blind randomized controlled trial with 1:1 split between the control and experimental groups. A total of 30 participants with type 2 diabetes were part of the study after obtaining the written informed consent. After recording the baseline values, the vestibular nerve stimulation was administered to the participants in the intervention group for 90 days. Sham stimulation was administered to the control group for 90 days. Outcome measures were recorded after 30 days and after 90 days of the intervention in both the groups. RESULTS: There was significant decrease in the total body weight, fasting, postprandial blood glucose, glycosylated hemoglobin levels, leptin, very low density lipoproteins levels followed by the intervention. There was significant improvement in both spatial and verbal memory scores. Depression and stress scores and systolic blood pressure decreased and remained in normal limits. CONCLUSIONS: The study results have proven multimodal action of vestibular stimulation. It not only acts on regulation of the glucose metabolism but also can regulate the autonomic activity and improve cognition and relieve stress. This is the interesting finding of our study, which needs detailed further research to support implementation of vestibular nerve stimulation as an adjunctive therapy in the management of diabetes.