Repeated electrical vestibular nerve stimulation (VeNS) reduces severity in moderate to severe insomnia; a randomised, sham-controlled trial; the modius sleep study.

BACKGROUND: Insomnia is a prevalent health concern in the general population associated with a range of adverse health effects. New, effective, safe and low-cost treatments, suitable for long-term use, are urgently required. Previous studies have shown the potential of electrical vestibular nerve stimulation (VeNS) in improving insomnia symptoms, however only one sham-controlled trial has been conducted on people with chronic insomnia. OBJECTIVES/HYPOTHESIS: Repeated VeNS delivered by the Modius Sleep device prior to sleep onset will show superior improvement in Insomnia Severity Index (ISI) scores over a 4-week period compared to sham stimulation. METHODS: In this double-blinded, multi-site, randomised, sham-controlled study, 147 participants with moderate to severe insomnia (ISI≥15) were recruited and allocated a VeNS or a sham device (1:1 ratio) which they were asked to use at home for 30 min daily (minimum 5 days per week) for 4 weeks. RESULTS: After 4 weeks, mean ISI score reduction was 2.26 greater in the VeNS treatment group than the sham group (p = 0.002). In the per protocol analysis, the treatment group had a mean ISI score decrease of 5.8 (95 % CI [-6.8, -4.81], approaching the clinically meaningful threshold of a 6-point reduction, with over half achieving a clinically significant decrease. Furthermore, the treatment group showed superior improvement to the sham group in the SF-36 (Quality of Life) energy/fatigue component (PP p = 0.004, effect size 0.26; ITT p = 0.006, effect size 0.22). CONCLUSIONS: Modius sleep has the potential to provide a viable, non-invasive and safe clinically meaningful alternative treatment option for insomnia.

A Cross-Sectional Study of Myopia and Morning Melatonin Status in Northern Irish Adolescent Children.

Purpose: Previous studies have demonstrated an association between melatonin status and both refractive error and axial length in young adult myopes. This study aimed to determine if this relationship extends to a younger adolescent cohort. Methods: Healthy children aged 12-15 years provided morning saliva samples before attending Ulster University (55°N) for cycloplegic autorefraction and axial length measures. Participants completed questionnaires describing recent sleep habits and physical activity. Salivary melatonin was quantified using high-performance liquid chromatography-tandem mass spectrometry. Data collection for all participants occurred over a 1-week period (April 2021). Results: Seventy participants aged 14.3 (95% CI: 14.2-14.5) years were categorised by spherical equivalent refraction [SER] (range: -5.38DS to +1.88DS) into two groups; myopic SER ≤ -0.50DS (n = 22) or nonmyopic -0.50DS < SER ≤ +2.00DS (n = 48). Median morning salivary melatonin levels were 4.52 pg/ml (95% CI: 2.60-6.02) and 4.89 pg/ml (95% CI: 3.18-5.66) for myopic and nonmyopic subjects, respectively, and did not differ significantly between refractive groups (P = 0.91). Melatonin levels were not significantly correlated with SER, axial length, sleep, or activity scores (Spearman's rank, all P > 0.39). Higher levels of physical activity were associated with higher sleep quality (Spearman's rank, ρ = -0.28, P = 0.02). Conclusion: The present study found no significant relationship between morning salivary melatonin levels and refractive error or axial length in young adolescents. This contrasts with outcomes from a previous study of adults with comparable methodology, season of data collection, and geographical location. Prospective studies are needed to understand the discrepancies between adult and childhood findings and evaluate whether melatonin levels in childhood are indicative of an increased risk for future onset of myopia and/or faster axial growth trajectories and myopia progression in established myopes. Future work should opt for a comprehensive dim-light melatonin onset protocol to determine circadian phase.

The Effectiveness of Electrical Vestibular Stimulation (VeNS) on Symptoms of Anxiety: Study Protocol of a Randomized, Double-Blinded, Sham-Controlled Trial.

The prevalence of symptoms of anxiety is increasing, especially during the COVID-19 pandemic. A home use transdermal neurostimulation device might help to minimize the severity of anxiety disorder. To the best of our knowledge, there is no clinical trial using transdermal neurostimulation to treat individuals with symptoms of anxiety in Asia. This gives us the impetus to execute the first study which aims at evaluating the efficacy of Electrical Vestibular Stimulation (VeNS) on anxiety in Hong Kong. This study proposes a two-armed, double-blinded, randomized, sham-controlled trial including the active VeNS and sham VeNS group. Both groups will be measured at baseline (T1), immediately after the intervention (T2), and at the 1-month (T3) and 3-month follow-up (T4). A total of 66 community-dwelling adults aged 18 to 60 with anxiety symptoms will be recruited in this study. All subjects will be computer randomised into either the active VeNS group or the sham VeNS group in a 1:1 ratio. All subjects in each group will receive twenty 30 min VeNS sessions during weekdays, which will be completed in a 4-week period. Baseline measurements and post-VeNS evaluation of the psychological outcomes (i.e., anxiety, insomnia, and quality of life) will also be conducted on all participants. The 1-month and 3-month follow-up period will be used to assess the long-term sustainability of the VeNS intervention. For statistical analysis, ANOVA with repeated measures will be used to analyze data. Missing data were managed with multiple mutations. The level of significance will be set to p < 0.05. Results of this study will be used to determine whether this VeNS device can be considered as a self-help technological device to reduce perceived anxiety in the general population in the community setting. This clinical Trial was registered with the Clinical Trial government, identifier: NCT04999709.

Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial.

Insomnia is a common health problem in the general population. There are different ways to improve sleeping habits and quality of sleep; however, there is no clinical trial using transdermal neurostimulation to treat individuals with symptoms of insomnia in Asia. This gives us the impetus to execute the first study in Asia which aims to evaluate the efficacy of Electrical Vestibular Stimulation (VeNS) on individuals with insomnia in Hong Kong. This study proposes a two-armed, double-blinded, randomized, sham-controlled trial including the active VeNS and sham VeNS group. Both groups will be measured at baseline (T1), immediately after the intervention (T2), and at the 1-month (T3) and 3-month follow-up (T4). A total of 60 community-dwelling adults aged 18 to 60 years, with insomnia symptoms will be recruited in this study. All subjects will be computer randomized into either the active VeNS group or the sham VeNS group on a 1:1 ratio. All subjects in each group will receive twenty 30-min VeNS sessions during weekdays, which will be completed in a 4-week period. Baseline measurements and post-VeNS evaluation of the psychological outcomes (i.e., insomnia severity, sleep quality and quality of life) will also be conducted on all participants. The 1-month and 3-month follow-up period will be used to assess the short-and long-term sustainability of the VeNS intervention. For statistical analysis, a mixed model will be used to analyze the repeated measures data. Missing data will be managed by multiple imputations. The level of significance will be set to p < 0.05. Significance of the study: The results of this study will be used to determine whether this VeNS device can be considered as a self-help technological device to reduce the severity of insomnia in the community setting. We registered this clinical trial with the Clinical trial government, identifier: NCT04452981.

Elevated Melatonin Levels Found in Young Myopic Adults Are Not Attributable to a Shift in Circadian Phase.

Purpose: To evaluate the relationship between refractive error, circadian phase, and melatonin with consideration of prior light exposure, physical activity, and sleep. Methods: Healthy young myopic (spherical equivalent refraction [SER] ≤-0.50DS) and emmetropic adults underwent noncycloplegic autorefraction and axial length (AL) measures. Objective measurements of light exposure, physical activity, and sleep were captured across 7 days by wrist-worn Actiwatch-2 devices. Questionnaires assessed sleep quality and chronotype. Hourly evening saliva sampling during a dim-light melatonin onset (DLMO) protocol evaluated circadian phase, and both morning serum and saliva samples were collected. Liquid chromatography/mass spectrometry quantified melatonin. Results: Subjects (n = 51) were aged 21.4 (interquartile range, 20.1-24.0) years. Melatonin was significantly higher in the myopic group at every evening time point and with both morning serum and saliva sampling (P ≤ 0.001 for all). DLMO-derived circadian phase did not differ between groups (P = 0.98). Multiple linear regression analysis demonstrated significant associations between serum melatonin and SER (B = -.34, ß = -.42, P = 0.001), moderate activity (B = .009, ß = .32, P = 0.01), and mesopic illumination (B = -.007, ß = -.29, P = 0.02), F(3, 46) = 7.23, P < 0.001, R2 = 0.32, R2adjusted = .28. Myopes spent significantly more time exposed to "indoor" photopic illumination (3 to ≤1000 lux; P = 0.05), but "indoor" photopic illumination was not associated with SER, AL, or melatonin, and neither sleep, physical activity, nor any other light exposure metric differed significantly between groups (P > 0.05 for all). Conclusions: While circadian phase is aligned in adult myopes and emmetropes, myopia is associated with both elevated serum and salivary melatonin levels. Prospective studies are required to ascertain whether elevated melatonin levels occur before, during, or after myopia development.

Infant-feeding attitudes of expectant mothers in Northern Ireland.

Northern Ireland (NI) has one of the lowest rates of breast-feeding initiation and duration in both the UK and the industrialized world. This study therefore aimed to explore the relationship between infant-feeding attitudes and feeding intention and outcome in expectant mothers within NI. Expectant mothers (n = 200) were recruited from hospital antenatal booking clinics. Each completed a demographic questionnaire and the self-administered Iowa Infant Feeding Attitude Scale (IIFAS). Participants (n = 192) were followed up after birth through the Northern Ireland Maternity System. The IIFAS distinguished between those mothers who intended to breast-feed (higher IIFAS scores) and those who intended to artificially feed (lower IIFAS scores) as well as between those who breast-fed and those who artificially fed on discharge from hospital. The IIFAS was also able to distinguish between mothers in regard to feeding intention and outcome on the basis of education, socio-economic class, income and marital status. This suggests that the IIFAS could prove useful in the targeting and evaluation of intervention to promote breast-feeding.

Smoking and peer groups: results from a longitudinal qualitative study of young people in Northern Ireland.

Previous research has indicated that young people are under considerable social pressure to take up smoking. This study has therefore sought to explore and better understand the mechanisms through which peer-related social factors operate to encourage young people to smoke. Individual qualitative interviews were held with adolescent children aged 11-12 years (N = 102) within youth clubs based in economically deprived areas of Northern Ireland, and then followed up on two occasions during the subsequent 3 years (N = 51/39). The data implied that, although peers influence smoking uptake, this seldom happens through direct persuasion, but rather as the result of the young person striving to conform to the normative behaviour of the peer group with which they identify. The findings are consistent with social identity theory and self-categorization theory in that for both smoking and nonsmoking 14-year-olds smoking activity appears to provide a means through which to define social groups, to accentuate similarity within groups and differences between groups. In-group favouritism was expressed in the sharing of cigarettes within the in-group and in the negative stereotyping of out-group members. There was some evidence that group affiliation may be negotiated differently for boys and girls. These findings imply that successful intervention needs to reconsider the normative processes that encourage young people to smoke.

Hard boys, attractive girls: expressions of gender in young people's conversations on smoking in Northern Ireland.

Health behaviour and attitudes among young people can be interpreted within the context of personal and social identity. This paper explores ways in which 10- to 11-year-olds in Northern Ireland expressed perceptions of gender ideology while discussing the topic of smoking. The data were gathered by means of in-depth interviews (n=85). Although few had tried smoking, the positive quality of their own gender appeared to be expressed through negative assessment of smokers of the opposite gender, and on different ideas of perceived gender dimensions in adult smoking. In order to deliver successful health promotion interventions, it is crucial to understand and address differences based on gender as it may partly explain differences in smoking experimentation and prevalence.