Magnesium Supplementation for Sleep Improvement in Adults
Magnesium 250 mg
Otro tipo de estudio
Resumen
Fecha de inicio: 15 de febrero de 2023
Fecha en la que se inscribió al primer participante.This study focuses on improving sleep health through the use of magnesium supplements. It involves 60 participants who experience sleep issues. The goal is to understand if magnesium can enhance sleep quality, addressing the need for better sleep solutions. Participants are required to consume a daily magnesium supplement of 250mg over a period of 56 days. During the study, participants visit a Sleep Lab three times. The first visit involves receiving an actiwatch, a device that monitors sleep patterns for seven nights. On the second visit, participants return the actiwatch, receive a new one, and get their magnesium supplement. They also complete a diet recall and a gastrointestinal symptoms questionnaire. The final visit includes returning the actiwatch and any leftover supplements, followed by a debriefing. The study measures sleep efficiency, sleep onset latency, total sleep time, and wake after sleep onset using actigraphy. It also evaluates dietary habits, gastrointestinal symptoms, anxiety levels, and depression symptoms through various questionnaires.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 65 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro Tipo de Estudio
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 39 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Inclusion Criteria: * Healthy male or female adult between the ages of 18 and 39 years of age. * Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week) * Are a fluent English speaker * Diet which is low in magnesium * Self-identify as a poor sleeper (i.e. poor sleep quality or unrefreshing sleep). Exclusion Criteria: * Have symptoms of COVID-19 * Display evidence of current or recent sleep disorders (e.g. sleep apnea, insomnia, circadian rhythm disorders); an initial screening for sleep disorders will be conducted using the Sleep Disorders Screening Checklist - 25 (SDS-CL). Have a history of seizures or epilepsy * Have recently (within the last 12 weeks) had an infection and/or used antibiotic medication * Are pregnant, seeking to become pregnant or lactating * Are a shift worker or a recent history of shift work in the previous 6 months * Are participating in other intervention research trials * Have experienced travel across multiple time zones within the last three months or will be experiencing travel across multiple time zones during the study. * Have recently been diagnosed and/or treated for a mental health or substance use disorder. * Are currently unwell with anything that impacts sleep. * Are taking any medication which has a sedative effect * Are currently using medication which affects the central nervous system. * Are currently misusing alcohol or drugs.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalCentros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Northumbria Sleep Research, Northumbria University
Newcastle, United KingdomAbrir Northumbria Sleep Research, Northumbria University en Google Maps