Magnesium Supplement for Sleep Quality in Women With Poor Sleep
ConditionSleep Quality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-60
SponsorJacksonville University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 35-60 U.S.-based, fluent in English Insomnia Severity Index score ≥8 (poor/subclinical insomnia) and <22 (excluding severe clinical insomnia) No formal sleep disorder diagnosis Consistent bedtime routine (+/-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
Disqualifiers
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/child regularly wakening, excessive noise, snoring partner, pain condition, variable work/study schedule, or mid-to-late afternoon/evening caffeine intake) BMI ≥32 kg/m² 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
Trial design
Design model
Crossover
Treatments tested in this trial
Magnesium Breakthrough
Dietary supplementMagnesium supplement blend (BIOptimizers), 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.
Placebo
Dietary supplementMatched 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Sequence AB (Active-Placebo)Experimental treatment 2 interventions
Group B: Arm 2: Sequence BA (Placebo-Active)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)Secondary outcomes
1
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/vigor). 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.
Time frame
Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)2
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.
Time frame
Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)3
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.
Time frame
Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)4
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.
Time frame
Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)Sponsors and contacts
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Source ClinicalTrials.gov
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