Magnesium Supplement for Sleep Quality in Women With Poor Sleep

Overview

This study will test whether a magnesium supplement (Magnesium Breakthrough) improves sleep quality and mood in women ages 35 to 60 who have poor sleep but no diagnosed sleep disorder. Participants will take the magnesium supplement for two weeks and a matched placebo for two weeks, in random order, separated by a one-week washout period. Neither participants nor study staff will know which product is being taken during each period. Throughout the study, participants will wear an Oura Ring to track sleep patterns and will complete short daily and biweekly questionnaires about their sleep, mood, stress, and energy levels. The main measure of interest is change in sleep quality, assessed using a validated sleep questionnaire (the Pittsburgh Sleep Quality Index). The study will also look at effects on mood, stress, and objective sleep measures from the Oura Ring. All study activities - screening, consent, and data collection - are conducted remotely, so participants can take part from anywhere in the United States.

Poor sleep quality affects a substantial proportion of adults, and women are disproportionately affected, particularly during the perimenopausal and postmenopausal transition. While Cognitive Behavioral Therapy for Insomnia (CBT-I) remains the gold-standard non-pharmacological treatment, access is limited. Pharmacological options such as benzodiazepines and common sleep aids carry risks of dependence, tolerance, and next-day cognitive impairment, while their objective sleep benefits are often modest. This has fueled interest in nutritional approaches to sleep support. Magnesium is an essential mineral involved in numerous enzymatic processes relevant to neural and cardiovascular function. Suboptimal magnesium status is common and often undetected, and has been associated with shorter sleep duration and increased nocturnal awakenings. Emerging clinical trial evidence suggests magnesium supplementation may improve sleep efficiency, sleep onset latency, and subjective sleep quality, though the existing evidence base remains limited in scale and methodological rigor. This study uses a randomized, double-blind, placebo-controlled crossover design, in which each participant serves as her own control, receiving both the active supplement and a matched placebo in a randomized sequence separated by a washout period. This design offers greater statistical power than a parallel-group design for a within-subject outcome such as self-reported sleep quality, while controlling for between-person variability. The study uses fully decentralized methods: recruitment, screening, informed consent, and all data collection occur remotely via a secure digital platform, allowing participation from across the United States without requiring in-person site visits. Objective sleep data are collected continuously via a wearable device (Oura Ring), complementing validated self-report instruments to provide converging evidence across subjective and objective measures. An a priori age-moderator analysis will explore whether treatment response varies across the 35-60 age range, given known differences in sleep physiology across the perimenopausal transition. Analyses account for standard crossover trial considerations, including treatment sequence, period effects, and carryover, with a washout period and behavioral standardization instructions designed to minimize carryover between treatment conditions.