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Magnesium Supplement for Sleep Quality in Women With Poor Sleep

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.

Study design
This is a randomized, double-blind, placebo-controlled crossover study involving 50 women. Each participant will receive both the active supplement and a placebo.
What's involved
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.
Compensation
Not stated in the trial record.
Follow-up
Your sleep quality will be measured at the start of each treatment period and at the end of each two-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07708857

Magnesium Supplement for Sleep Quality in Women With Poor Sleep

Not Yet Recruiting
NAAges 35–60InterventionalTreatment
Jacksonville University
~50 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Magnesium BreakthroughPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score
Measured over Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)

Conditions

Sleep Quality

Explore related trials

Insomnia

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Heather Hausenblas, PhD · PRINCIPAL_INVESTIGATOR · Wellness Discovery Labs, Jacksonville University

Who to contact

Heather Hausenblas, PhD
[email protected]
904.891.9746
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global ScoreBaseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)

    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