Poor Sleep QualityMISITNCT07651514
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
A study testing Magnesium and melatonin based multi-ingredient dietary supplementation in people with Poor Sleep Quality and Leg Cramps, Nocturnal, run by StudySetGo at 7 sites in United States.
Trial summary
Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Sleep Quality, Leg Cramps, Nocturnal, Melatonin
- What is being tested?
- Magnesium and melatonin based multi-ingredient dietary supplementation
- 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
- 7 sitesUnited States
- Study dates
- 10 Oct 2026to 10 Sep 2027
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 40-75 years
- Self-reported poor sleep quality (PSQI >5) at screening
- Self-reported nocturnal leg cramp averaging ≥4 episodes per fortnight at screening
- Capacity to understand and provide electronic informed consent
- Willing to wear an Oura Ring wearable device continuously throughout the study period
- Access to a smartphone/tablet with iOS 15 or higher and Android 9 or higher and willing to install and use the Oura and Trialflare applications
- Be a resident of and permanently living in Florida with no planned travel across more than one time zone for at least 1 night during the study period
Who cannot join
- Current or recent (within 4 weeks of randomisation) use of melatonin, magnesium, or other supplements specifically taken for sleep or leg cramps or listed as an ingredient of the intervention supplement.
- Current use of any prescription medication
- Diagnosed sleep disorder (e.g. obstructive sleep apnoea, restless legs syndrome, insomnia disorder)
- Known or suspected secondary cause of nocturnal leg cramps (e.g. peripheral vascular disease, neurological condition, renal impairment, thyroid disorder)
- Any current or prior diagnosis of:
- Cancer or malignancy of any kind (prior malignancy is not exclusionary if the participant is in confirmed remission and has completed all treatment)
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- Cardiovascular disease (e.g. hypertension, coronary artery disease, heart failure, arrhythmia, stroke, peripheral vascular disease)
- Autoimmune disorder (e.g. rheumatoid arthritis, lupus, multiple sclerosis)
- Gastrointestinal disorder (e.g. IBS, malabsorption syndromes)
- Neurological disorder (e.g. epilepsy, Parkinson's disease, dementia)
- Hepatic or renal impairment
- Diabetes mellitus (type 1 or type 2)
- Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
- Myasthenia Gravis
- Known hypersensitivity or allergy to any ingredient in the active or placebo product
- Rotating shift work or irregular sleep patterns
- Current participation in another interventional clinical trial
- Inability to comply with study procedures or remote visit schedule
- Breastfeeding, pregnant, or planning to become pregnant during the study period
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Remote participation (home-based, no site visits)
Atlanta, Georgia, 30303
Christopher Koscien, PhD, 8886119860, misit@studysetgo.com
- Recruiting
Remote participation (home-based, no site visits)
Birmingham, Alabama, 35203
Christopher Koscien, PhD, 8886119860, misit@studysetgo.com
- Recruiting
Remote participation (home-based, no site visits)
Charleston, South Carolina, 29401
Christopher Koscien, PhD, 8886119860, misit@studysetgo.com
- Recruiting
Remote participation (home-based, no site visits)
Charlotte, North Carolina, 28202
Christopher Koscien, PhD, 8886119860, misit@studysetgo.com
- Recruiting
Remote participation (home-based, no site visits)
Little Rock, Arkansas, 72201
Christopher Koscien, PhD, 8886119860, misit@studysetgo.com
- Recruiting
Remote participation (home-based, no site visits)
Nashville, Tennessee, 37201
Christopher Koscien, PhD, 8886119860, misit@studysetgo.com
- Recruiting
Remote participation (home-based, no site visits)
Palm Beach Gardens, Florida, 33418
Tom Jameson, +44 7794865520, tom.jameson@studysetgo.com
About this study
Official title: An Investigation Into the Effect of a Daily Magnesium and Melatonin Based Multi-Ingredient Dietary Supplement on Sleep Quality in Individuals With Self-Reported Nighttime Leg Cramps.
Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve.
Purpose: This study will investigate whether a multi-ingredient nutritional supplement containing magnesium and melatonin can improve sleep quality in adults who experience disrupted sleep due to nighttime leg cramps.
Read more
What participation involves: Participation lasts 8 weeks. Participants will be randomly assigned to take either the nutritional supplement or a placebo (inactive look-alike) every night before bed for 6 weeks. Participants will wear an Oura Ring wearable device on one finger continuously for 8 weeks throughout the study and complete short questionnaires using a smartphone app. The Oura Ring and study supplement will be sent to the participant's home address. Participants will never need to travel to a research centre; all contact with the research team will be by video call, phone, messaging, or email.
How long: Total involvement will be 8 weeks, made up of a 2-week baseline period and a 6-week supplementation period. Each day, participants will complete a short app-based questionnaire (approximately 1 minute). At the end of weeks 2, 4, 6, and 8, participants will complete additional app-based questionnaires (approximately 10 minutes).
- Conditions
- Poor Sleep Quality, Leg Cramps, Nocturnal, Melatonin, Magnesium, Muscle Cramps
- Being tested
- Magnesium and melatonin based multi-ingredient dietary supplementation, Placebo
- Keywords
- Leg Cramps, Nocturnal, Poor Sleep quality, Muscle cramps, magnesium, Melatonin, nocturnal leg cramps, nighttime leg cramps, charley horse, calf cramps, sleep-related leg cramps, idiopathic leg cramps, poor sleep, trouble sleeping, disrupted sleep, waking at night, sleep supplement, dietary supplement
- Medical subject headings
- Sleep-Wake Transition Disorders, Muscle Cramp, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium and melatonin based multi-ingredient dietary supplementationDietary supplement
The active intervention is a commercially available multi-ingredient dietary supplement, supplied by Imagine Biolabs LLC (trading as SaltWrap) and sold under the brand name Mag R\&R. The dose is up to 3 capsules per day taken 30 minutes before bedtime with water. The product is stored at room temperature.
PlaceboOther
The placebo is manufactured by the same manufacturer that produces the active product (Vitaquest International, New Jersey, USA). The placebo is visually similar to the active product and will be packaged in the same plain bottles as the active intervention to maintain the blind. The placebo dose is up to 3 capsules per day taken with water. Packaging is managed by Vitaquest International.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium and melatonin based multi-ingredient dietary supplement | Experimental | Not described Receives: Dietary Supplement: Magnesium and melatonin based multi-ingredient dietary supplementation |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality over the past month. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (2)
36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a self-reported questionnaire assessing health-related quality of life across eight domains. Scale scores range from 0 to 100, with higher scores indicating better health.
Measured: From enrollment to the end of treatment at 6 weeks
REM sleep assessed via Oura Ring wearable
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StudySetGo
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651514
- Sponsor's protocol ID
- SSG-26-001-001
- Acronym
- MISIT
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Effect of a Daily Magnesium and Melatonin Based Multi-Ingredient Dietary Supplement on Sleep Quality in Individuals With Self-Reported Nighttime Leg Cramps.
- ClinicalTrials.gov ID
- NCT07651514
- Acronym / sponsor ID
- MISIT / SSG-26-001-001
- Conditions
- Poor Sleep Quality, Leg Cramps, Nocturnal, Melatonin, Magnesium, Muscle Cramps
- Keywords
- Leg Cramps, Nocturnal, Poor Sleep quality, Muscle cramps, magnesium, Melatonin, nocturnal leg cramps, nighttime leg cramps
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- StudySetGoResearch network
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 16 Jun 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.
Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve.
Purpose: This study will investigate whether a multi-ingredient nutritional supplement containing magnesium and melatonin can improve sleep quality in adults who experience disrupted sleep due to nighttime leg cramps.
What participation involves: Participation lasts 8 weeks. Participants will be randomly assigned to take either the nutritional supplement or a placebo (inactive look-alike) every night before bed for 6 weeks. Participants will wear an Oura Ring wearable device on one finger continuously for 8 weeks throughout the study and complete short questionnaires using a smartphone app. The Oura Ring and study supplement will be sent to the participant's home address. Participants will never need to travel to a research centre; all contact with the research team will be by video call, phone, messaging, or email.
How long: Total involvement will be 8 weeks, made up of a 2-week baseline period and a 6-week supplementation period. Each day, participants will complete a short app-based questionnaire (approximately 1 minute). At the end of weeks 2, 4, 6, and 8, participants will complete additional app-based questionnaires (approximately 10 minutes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium and melatonin based multi-ingredient dietary supplement | Experimental | Dietary Supplement: Magnesium and melatonin based multi-ingredient dietary supplementation |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 40-75 years
- Self-reported poor sleep quality (PSQI >5) at screening
- Self-reported nocturnal leg cramp averaging ≥4 episodes per fortnight at screening
- Capacity to understand and provide electronic informed consent
- Willing to wear an Oura Ring wearable device continuously throughout the study period
Key exclusion criteria (19 listed)
- Current or recent (within 4 weeks of randomisation) use of melatonin, magnesium, or other supplements specifically taken for sleep or leg cramps or listed as an ingredient of the intervention supplement.
- Current use of any prescription medication
- Diagnosed sleep disorder (e.g. obstructive sleep apnoea, restless legs syndrome, insomnia disorder)
- Known or suspected secondary cause of nocturnal leg cramps (e.g. peripheral vascular disease, neurological condition, renal impairment, thyroid disorder)
- Any current or prior diagnosis of:
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 and melatonin based multi-ingredient dietary supplementationThe active intervention is a commercially available multi-ingredient dietary supplement, supplied by Imagine Biolabs LLC (trading as SaltWrap) and sold under the brand name Mag R\&R. The dose is up to 3 capsules per day taken 30 minutes before bedtime with water. The product is stored at room temperature. | Dietary supplement | Magnesium and melatonin based multi-ingredient dietary supplement |
| PlaceboThe placebo is manufactured by the same manufacturer that produces the active product (Vitaquest International, New Jersey, USA). The placebo is visually similar to the active product and will be packaged in the same plain bottles as the active intervention to maintain the blind. The placebo dose is up to 3 capsules per day taken with water. Packaging is managed by Vitaquest International. | Other | Placebo |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment to the end of treatment at 6 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality over the past month. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
2 secondary outcomes
36-Item Short Form Health Survey (SF-36)
Time frame: From enrollment to the end of treatment at 6 weeks
REM sleep assessed via Oura Ring wearable
Time frame: From enrollment to the end of treatment at 6 weeks
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium and melatonin based multi-ingredient dietary supplementation in people with Poor Sleep Quality and Leg Cramps, Nocturnal, run by StudySetGo at 7 sites 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 7 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 MISIT Study Team (+18886119860, misit@studysetgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: From enrollment to the end of treatment at 6 weeks). 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 2 Nov 2026.