[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07708857":3,"trial-entities:NCT07708857":112,"trial-summary:NCT07708857":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":81,"locations":83,"central_contacts":103,"overall_officials":106,"references":110,"see_also_links":111},"NCT07708857","WDL-MAG-001","Magnesium Supplement for Sleep Quality in Women With Poor Sleep","Effects of Magnesium Breakthrough on Sleep Quality and Mood in Women With Poor Sleep: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial","NOT_YET_RECRUITING","2026-11","2026-07","2026-07-20","2026-09","Jacksonville University","OTHER",false,"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.\n\nThroughout 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.\n\nAll 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.\n\nMagnesium 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.\n\nThis 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.\n\nThe 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.\n\nAn 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.",[19],"Sleep Quality",[21,22,23,24],"magnesium","sleep quality","crossover trial","middle-aged women","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},50,"ESTIMATED",[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","Magnesium Breakthrough","Magnesium supplement blend (BIOptimizers), 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.",[38,39],"Arm 1: Sequence AB (Active-Placebo)","Arm 2: Sequence BA (Placebo-Active)",{"type":34,"name":41,"description":42,"armGroupLabels":43},"Placebo","Matched placebo capsules, identical in color, taste, smell, and packaging to Magnesium Breakthrough; 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.",[38,39],[45],{"measure":46,"description":47,"timeFrame":48},"Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score","The Pittsburgh Sleep Quality Index, modified 2-week recall version (PSQI-2w), is a validated self-report questionnaire assessing subjective sleep quality. Global scores range from 0 to 21, with scores greater than 5 indicating clinically meaningful poor sleep quality. The minimal clinically important difference (MCID) is 3 points. Change in global score will be calculated from period baseline to the end of each 2-week treatment period, comparing the magnesium supplementation condition to the placebo condition using a linear mixed-effects model accounting for treatment, sequence, and period effects. Higher scores indicate worse sleep quality. A higher score = greater poor sleep quality. A global score \\>5 is the standard cutoff used to distinguish \"poor\" from \"good\" sleepers","Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)",[50,54,57,61,64,67],{"measure":51,"description":52,"timeFrame":53},"Change in Profile of Mood States (POMS) Score","The Profile of Mood States is a validated self-report questionnaire assessing mood disturbance across multiple subscales. The 40-item short form of the POMS-40, which measures six domains will be used: tension, anger, vigor, fatigue, depression, and confusion. A Total Mood score will be calculated. Change in total mood disturbance score will be calculated from baseline to the end of each treatment period, comparing the magnesium supplementation condition to placebo. On the five negative subscales (Tension, Depression, Anger, Fatigue, Confusion) higher scores = worse, more disturbance in that mood state. On Vigor higher scores = better (more energy\u002Fvigor). A Total Mood Disturbance score is calculated by summing the five negative subscales and subtracting Vigor-Activity. Each of the 40 items are rated on a 5-point Likert scale: where 0=\"not at all\" and 4 =\"extremely\". Score range is 0 to 120.","Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)",{"measure":55,"description":56,"timeFrame":53},"Change in Perceived Stress Scale (PSS) Score","The Perceived Stress Scale is a validated self-report measure of perceived stress over the preceding period. Change in score will be calculated from baseline to the end of each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model. Perceived Stress Scale (PSS): higher scores also mean greater perceived stress. The four item PSS will be used. The scores range of 0 to 16.",{"measure":58,"description":59,"timeFrame":60},"Change in Oura Ring Sleep Efficiency","Sleep efficiency (percentage of time in bed spent asleep) will be measured continuously via Oura Ring and averaged weekly for each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model.","Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)",{"measure":62,"description":63,"timeFrame":60},"Change in Oura Ring Total Sleep Time","Total sleep time will be measured continuously via Oura Ring and averaged weekly for each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model.",{"measure":65,"description":66,"timeFrame":60},"Change in Oura Ring Sleep Onset Latency","Sleep onset latency (time in minutes to fall asleep) will be measured continuously via Oura Ring and averaged weekly for each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model.",{"measure":68,"description":69,"timeFrame":70},"Daily Visual Analogue Scale (VAS) Ratings for Sleep Quality, Energy, Fatigue, and Mood","Participants will complete daily visual analogue scale ratings (0-100) each morning during active treatment periods, assessing subjective sleep quality, energy, fatigue, and mood.","Daily, throughout Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)","FEMALE","35 Years","60 Years",true,{"inclusion":76,"exclusion":78,"raw_text":80},[77],"Women aged 35-60 U.S.-based, fluent in English Insomnia Severity Index score ≥8 (poor\u002Fsubclinical insomnia) and \\\u003C22 (excluding severe clinical insomnia) No formal sleep disorder diagnosis Consistent bedtime routine (+\u002F-1 hr) Not currently using prescription sleep medications Owns a compatible smartphone (iOS or Android) capable of running the Oura Ring app and study digital platform Willing to wear the Oura Ring throughout the entire study period Nonsmoker Able to provide informed consent and complete all activities",[79],"Diagnosed sleep disorder Current diagnosis of depression or anxiety disorder Current use of bisphosphonates (e.g., alendronate, risedronate) Shift worker or highly irregular sleep schedule Pregnancy or breastfeeding Known sensitivity to product ingredients Current use of supplements containing more than 25 mg of elemental magnesium Coffee intake greater than 3 cups per day (or equivalent caffeine from other beverages) External or lifestyle factors that may affect sleep patterns (e.g., infant\u002Fchild regularly wakening, excessive noise, snoring partner, pain condition, variable work\u002Fstudy schedule, or mid-to-late afternoon\u002Fevening caffeine intake) BMI ≥32 kg\u002Fm² Current diagnosis of chronic kidney disease or renal impairment, or current use of prescription diuretics Use of melatonin \\>1 mg within 14 days of baseline Recent major life event or acute psychosocial stressor within 30 days of baseline (e.g., bereavement, job loss, separation) that may independently disrupt sleep Participation in other clinical trials in past 30 days","Inclusion Criteria:\n\n* Women aged 35-60 U.S.-based, fluent in English Insomnia Severity Index score ≥8 (poor\u002Fsubclinical insomnia) and \\\u003C22 (excluding severe clinical insomnia) No formal sleep disorder diagnosis Consistent bedtime routine (+\u002F-1 hr) Not currently using prescription sleep medications Owns a compatible smartphone (iOS or Android) capable of running the Oura Ring app and study digital platform Willing to wear the Oura Ring throughout the entire study period Nonsmoker Able to provide informed consent and complete all activities\n\nExclusion Criteria:\n\n* Diagnosed sleep disorder Current diagnosis of depression or anxiety disorder Current use of bisphosphonates (e.g., alendronate, risedronate) Shift worker or highly irregular sleep schedule Pregnancy or breastfeeding Known sensitivity to product ingredients Current use of supplements containing more than 25 mg of elemental magnesium Coffee intake greater than 3 cups per day (or equivalent caffeine from other beverages) External or lifestyle factors that may affect sleep patterns (e.g., infant\u002Fchild regularly wakening, excessive noise, snoring partner, pain condition, variable work\u002Fstudy schedule, or mid-to-late afternoon\u002Fevening caffeine intake) BMI ≥32 kg\u002Fm² Current diagnosis of chronic kidney disease or renal impairment, or current use of prescription diuretics Use of melatonin \\>1 mg within 14 days of baseline Recent major life event or acute psychosocial stressor within 30 days of baseline (e.g., bereavement, job loss, separation) that may independently disrupt sleep Participation in other clinical trials in past 30 days\n\nCriteria:\" as headers within a single text field)?",[82],"ADULT",[84],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":100},"Wellness Discovery Labs","Jacksonville","Florida","32202","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Heather Hausenblas, PhD","CONTACT","904.891.9746","hhausenblas@wellnessdiscoverylabs.com",{"name":97,"role":93,"phone":98,"email":99},"Stephanie Hooper, MPH","908.868.8740","shooper@wellnessdiscoverylabs.com",{"lat":101,"lon":102},30.33218,-81.65565,[104,105],{"name":92,"role":93,"phone":94,"email":95},{"name":97,"role":93,"phone":98,"email":99},[107],{"name":92,"affiliation":108,"role":109},"Wellness Discovery Labs, Jacksonville University","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Insomnia",[],{"nct_id":4,"found":74,"summary":117,"prompt_version":126},{"design":118,"status":119,"heading":6,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a randomized, double-blind, placebo-controlled crossover study involving 50 women. Each participant will receive both the active supplement and a placebo.","completed","This study is looking at whether a magnesium supplement called Magnesium Breakthrough can improve sleep quality in women aged 35 to 60 who experience poor sleep but haven't been diagnosed with a sleep disorder. You would take Magnesium Breakthrough for two weeks and a matching placebo (an inactive substance) for two weeks, in a random order. Neither you nor the study staff will know which you are taking at any given time. The main goal is to see if your sleep quality, measured by a questionnaire called the Pittsburgh Sleep Quality Index, changes. We are currently recruiting 50 women for this study.","Your sleep quality will be measured at the start of each treatment period and at the end of each two-week treatment period.",102,"You will take capsules nightly for two weeks, followed by a one-week break, and then take different capsules for another two weeks. You will also wear an Oura Ring and complete daily and biweekly questionnaires.","Not stated in the trial record.",[35,41],"v2"]