Sleep QualityNCT07708857
Magnesium Supplement for Sleep Quality in Women With Poor Sleep
A study testing Magnesium Breakthrough in people with Sleep Quality, run by Jacksonville University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Magnesium Breakthrough
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Criteria:" as headers within a single text field)?
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wellness Discovery Labs
Jacksonville, Florida, 32202
Heather Hausenblas, PhD, 904.891.9746, hhausenblas@wellnessdiscoverylabs.com
Stephanie Hooper, MPH, 908.868.8740, shooper@wellnessdiscoverylabs.com
About this study
Official title: Effects of Magnesium Breakthrough on Sleep Quality and Mood in Women With Poor Sleep: A Randomized, Double-Blind, Placebo-Controlled Crossover 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.
Read the detailed description
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.
- Conditions
- Sleep Quality
- Being tested
- Magnesium Breakthrough, Placebo
- Keywords
- magnesium, sleep quality, crossover trial, middle-aged women
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium BreakthroughDietary supplement
Magnesium supplement blend (BIOptimizers), 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Sequence AB (Active-Placebo) | Experimental | Not described Receives: Dietary Supplement: Magnesium Breakthrough; Dietary Supplement: Placebo |
| Arm 2: Sequence BA (Placebo-Active) | Experimental | Not described Receives: Dietary Supplement: Magnesium Breakthrough; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)
Secondary outcomes (6)
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.
Measured: Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)
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.
Measured: Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)
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.
Measured: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
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.
Measured: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
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.
Measured: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
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.
Measured: Daily, throughout Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacksonville University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Hausenblas, PhD, Principal investigator, Wellness Discovery Labs, Jacksonville University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708857
- Sponsor's protocol ID
- WDL-MAG-001
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data will be made available upon reasonable written request to the Principal Investigator following publication of the primary trial results. Requests will be reviewed by the Principal Investigator and BIOptimizers. Data will be shared in a secure format consistent with participant confidentiality protections and applicable data privacy regulations. Any embargo period and specific data sharing terms will be defined in the final executed sponsor agreement between BIOptimizers and Wellness Discovery Labs.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Breakthrough on Sleep Quality and Mood in Women With Poor Sleep: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT07708857
- Acronym / sponsor ID
- WDL-MAG-001
- Conditions
- Sleep Quality
- Keywords
- magnesium, sleep quality, crossover trial, middle-aged women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jacksonville UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sequence AB (Active-Placebo) | Experimental | Dietary Supplement: Magnesium Breakthrough, Dietary Supplement: Placebo |
| Arm 2: Sequence BA (Placebo-Active) | Experimental | Dietary Supplement: Magnesium Breakthrough, Dietary Supplement: Placebo |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- Criteria:" as headers within a single text field)?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium BreakthroughMagnesium supplement blend (BIOptimizers), 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks. | Dietary supplement | Arm 1: Sequence AB (Active-Placebo), Arm 2: Sequence BA (Placebo-Active) |
| PlaceboMatched 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. | Dietary supplement | Arm 1: Sequence AB (Active-Placebo), Arm 2: Sequence BA (Placebo-Active) |
Primary outcome
Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score
Time frame: Baseline (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
6 secondary outcomes
Change in Profile of Mood States (POMS) Score
Time frame: Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)
Change in Perceived Stress Scale (PSS) Score
Time frame: Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)
Change in Oura Ring Sleep Efficiency
Time frame: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Change in Oura Ring Total Sleep Time
Time frame: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Change in Oura Ring Sleep Onset Latency
Time frame: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Daily Visual Analogue Scale (VAS) Ratings for Sleep Quality, Energy, Fatigue, and Mood
Time frame: Daily, throughout Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data will be made available upon reasonable written request to the Principal Investigator following publication of the primary trial results. Requests will be reviewed by the Principal Investigator and BIOptimizers. Data will be shared in a secure format consistent with participant confidentiality protections and applicable data privacy regulations. Any embargo period and specific data sharing terms will be defined in the final executed sponsor agreement between BIOptimizers and Wellness Discovery Labs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Hausenblas, PhD principal investigator
Wellness Discovery Labs, Jacksonville University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Breakthrough in people with Sleep Quality, run by Jacksonville University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Hausenblas, PhD (904.891.9746, hhausenblas@wellnessdiscoverylabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score (time frame: Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.