Improve sleep in critically ill patients: Study protocol for a randomized controlled trial for a multi-component intervention of environment control in the ICU.

INTRODUCTION: In critically ill patients, sleep and circadian rhythms are greatly altered. These disturbances have been associated with adverse consequences, including increased mortality. Factors associated with the ICU environment, such as exposure to inadequate light and noise levels during the day and night or inflexible schedules of daily care activities, have been described as playing an essential role in sleep disturbances. The main objective of this study is to evaluate the impact of the use of a multifaceted environmental control intervention in the ICU on the quantity and quality of sleep, delirium, and post-intensive care neuropsychological impairment in critically ill patients. METHODS: This is a prospective, parallel-group, randomized trial in 56 critically ill patients once they are starting to recover from their acute illness. Patients will be randomized to receive a multifaceted intervention of environmental control in the ICU (dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient care activities) or standard care. The protocol will be applied from enrollment until ICU discharge. Baseline parameters, light and noise levels, polysomnography and actigraphy, daily oscillation of plasma concentrations of Melatonin and Cortisol, and questionnaires for the qualitative evaluation of sleep, will be assessed during the study. In addition, all patients will undergo standardized follow-up before hospital discharge and at 6 months to evaluate neuropsychological impairment. DISCUSSION: This study is the first randomized clinical trial in critically ill patients to evaluate the effect of a multicomponent, non-pharmacological environmental control intervention on sleep improvement in ICU patients. The results will provide data about the potential synergistic effects of a combined multi-component environmental intervention in ICU on outcomes in the ICU and long term, and the mechanism of action. TRIAL REGISTRATION: ClinicalTrials.gov, NCT. Registered on January 10, 2023. Last updated on 24 Jan 2023.

Síndrome de piernas inquietas en niños: caracterización clínica / Characterization of restless leg syndrome in children

El Síndrome de piernas inquietas (SPI) o Enfermedad de Willis­Ekbom, es una condición neurológica que afecta al 2-4% de los niños en edad escolar. Etiológicamente se ha relacionado al metabolismo del hierro y a factores genéticos entre otros. En niños aun es una patología poco diagnosticada. Trabajo observacional descriptivo, en el cual se realiza caracterización clínica, según criterios internacionales, en 14 pacientes menores de 18 años, 9 varones. Edad promedio 8 años. Sintomatología inicial variada, desde resistencia a ir a la cama, hasta dibujar sus molestias. En 10 se comprobó déficit de hierro. En 11 pacientes se realizó un polisomnograma, 10 de ellos con un índice elevado de movimientos periódicos de extremidades. El uso de pregabalina y aporte de hierro fue el tratamiento más utilizado. Dos pacientes tenían padres diagnosticados con SPI.

Abstract. The Restless Legs Syndrome (RLS) or Willis-Ekbom Disease is a neurological condition that affects 2-4% of school-age children. Its etiology has been related to the metabolism of iron and genetic factors among others. In children it is still a frequently undiagnosed disorder. This is a descriptive observational report, in which clinical characterization is carried out according to international criteria in 14 patients under 18 years old, 9 boys. Average age is 8 years old. The initial symptomatology was varied, from resistance to comply with bedtime, to drawing their discomfort. In 9, iron deficiency was found. A polysomnogram was performed in 11 patients, 10 of which had a high periodic limb movements index. The use of pregabalin and supplementary iron were the most used treatments. Two patients had parents diagnosed with RLS.