Clinical trial for Poor Sleep Quality
Official title The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
ClinicalTrials.gov ID: NCT07651514
What this study is testing
- What it's testing
- The study wants to find out whether taking a daily supplement of magnesium and melatonin improves sleep quality for people who have leg cramps at night.
- Who it's for
- Adults who have poor sleep because of nighttime leg cramps.
- What's involved
- Participants will take either the supplement or a placebo every night for 6 weeks, wear an Oura Ring on a finger all the time for 8 weeks, and answer short questionnaires on a smartphone app. All supplies are mailed and all contact is remote.
- Time commitment
- The study lasts 8 weeks: 2 weeks of baseline and 6 weeks of taking the supplement or placebo, with daily short app surveys and additional surveys at weeks 2, 4, 6, and 8.
- Time commitment: about 8 weeks
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Current or recent (within 4 weeks of randomisation) use of melatonin, magnesium, or other supplements specifically taken for sleep or leg cramps or...
- 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...
- Cancer or malignancy of any kind (prior malignancy is not exclusionary if the participant is in confirmed remission and has completed all treatment)
- Cardiovascular disease (e.g. hypertension, coronary artery disease, heart failure, arrhythmia, stroke, peripheral vascular disease)
See the full eligibility criteria
- 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
- 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)
- Cancer or malignancy of any kind (prior malignancy is not exclusionary if the participant is in confirmed remission and has completed all treatment)
- 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 treatment clinical trial
- Inability to comply with study procedures or remote visit schedule
- Breastfeeding, pregnant, or planning to become pregnant during the study period
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Palm Beach Gardens, Florida, United States
- Atlanta, Georgia, United States
- Charlotte, North Carolina, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Palm Beach Gardens, Florida, United States; Atlanta, Georgia, United States; Charlotte, North Carolina, United States; Charleston, South Carolina, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.