The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps (NCT07651514)
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.
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: StudySetGo Decentralised team โ Palm Beach Gardens, Florida
Age range: 40 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- StudySetGo Decentralised team โ Palm Beach Gardens, Florida
๐ Contact the Study Coordinator
Phone: +447794865520
Email: tom.jameson@studysetgo.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.