Auricular Vagal Neuromodulation Therapy Improves Sleep Score in Long COVID: A pilot study

Abstract

Nurosym Auricular Vagal Neuromodulation Therapy (AVNT) was performed to assess improvement in the sleep quality among Post-Viral patients with cognitive impairments. Participants underwent a 10-day course of AVNT at home, with twice-daily sessions. The study measured sleep quality using the PROMIS Sleep Disturbance. Results demonstrated a significant improvement in sleep quality, with sleep disturbance scores decreasing by 19% post-intervention and maintaining this improvement at the one-month follow-up. The findings suggest that Nurosym can positively and sustainably impact sleep quality by enhancing parasympathetic activity. This study underscores Nurosym as a novel approach for addressing sleep disorders, although further research is needed to determine the mechanisms of long-lasting effects.

Background and aims

This clinical trial involved female patients, who have been experiencing persistent symptoms of Long COVID, specifically cognitive impairments. Notably, 37.5% of the participants had pre-existing anxiety or depression. Participants underwent a 10-day course of Nurosym, administered at home. Each day consisted of two 30-minute sessions - one in the morning and one in the evening. The intensity of the current was personalised for each participant, adjusted to achieve a constant tingling sensation without discomfort. The study outcomes included sleep quality, assessed using the PROMIS Sleep Disturbance - Short Form, which ranges from 8 to 40, with higher scores indicating greater sleep disruption. Data analysis involved both parametric and non-parametric statistical tests to accommodate the normality of data distribution, with effect sizes calculated for each significant finding.

Methods

Research shows that a significant proportion of adults, including more than 40% in some studies, suffer from less than the recommended six hours of sleep a night, which is associated with risks including cardiovascular disease, diabetes, obesity and even cognitive decline and depression. Moreover, traditional treatments for serious sleep disorders, such as pharmacotherapy and cognitive behavioural therapy for insomnia (CBT-I), often face limitations, including side effects, potential for addiction, and lack of available specialised therapists. Stimulating the vagus nerve, which plays a key role in regulating the autonomic nervous system and inflammatory responses, has potential to improve sleep quality by supporting a balance that promotes a smooth transition between wakefulness and sleep. In this context, Nurosym which targets branches of the vagus nerve, could be a new and promising approach.

Results

The study showed a statistically significant improvement in PROMIS sleep disturbance scores in the Nurosym stimulation group, indicating the effectiveness of transcutaneous vagus nerve stimulation in improving sleep quality. The effect may correlate with the stimulation of the vagus nerve, which is thought to facilitate entry into deeper stages of sleep by increasing parasympathetic activity.

(Figure) Changes in sleep (PROMIS Sleep Disturbance) across three timepoints: pre-intervention, post-intervention, and 1-month follow-up. Boxplots are used for nonparametric data, whereas column graphs depict parametric data. Error bars reflect standard error. *p < 0.05.

Sleep study results showed significant improvement after intervention (10 days) and at 1-month follow-up. Specifically, sleep scores improved from baseline to post intervention by 19% (p = 0.036, r = 0.6) and stayed at the similar level after 1-month follow-up (p = 0.021, r = 0.66). These improvements indicate that vagal neuromodulation therapy had a positive and lasting effect on sleep disturbances among participants.

Conclusion

The prevalence of poor sleep quality and insufficient sleep duration in the general population highlights the critical need for effective interventions to improve sleep quality and duration. Preliminary research in this clinical population suggests that a ten day course of Nurosym improves sleep quality, offering a potential new tool to address common sleep problems in adults. Although preliminary research supports the practical use of Nurosym in the treatment of sleep disorders that have significant public health implications, further research is necessary to conclusively establish that Nurosym is an effective treatment for the common problem of poor sleep.