Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 40 and 75 years of age
• People who report poor sleep quality, based on a standard sleep questionnaire score above 5 at the screening stage
• People who report experiencing leg cramps at night averaging 4 or more episodes per fortnight at the screening stage
• People who are able to understand and give consent to participate electronically
• People who are willing to wear an Oura Ring device continuously throughout the study
• People who have access to a smartphone or tablet running iOS 15 or higher, or Android 9 or higher, and who are willing to install and use the Oura and Trialflare apps
• People who permanently live in Florida and have no plans to travel across more than one time zone for at least one night during the study period

Who may not be able to join:

• People who are currently using, or have used in the past 4 weeks, melatonin, magnesium, or other supplements taken specifically for sleep or leg cramps, or any supplement containing ingredients used in the trial product
• People who are currently taking any prescription medication
• People who have been diagnosed with a sleep disorder, such as sleep apnoea, restless legs syndrome, or insomnia disorder
• People whose leg cramps are thought to be caused by an underlying condition, such as a circulation problem, nerve condition, kidney issue, or thyroid disorder
• People who have ever been diagnosed with cancer or a malignancy of any kind, unless they are in confirmed remission and have completed all treatment
• People who have a current or prior diagnosis of a heart or blood vessel condition, such as high blood pressure, coronary artery disease, heart failure, irregular heartbeat, stroke, or circulation problems in the limbs
• People who have a current or prior diagnosis of an autoimmune condition, such as rheumatoid arthritis, lupus, or multiple sclerosis
• People who have a current or prior diagnosis of a digestive condition, such as irritable bowel syndrome or a condition affecting nutrient absorption
• People who have a current or prior diagnosis of a neurological condition, such as epilepsy, Parkinson's disease, or dementia
• People who have a current or prior diagnosis of liver or kidney impairment
• People who have a current or prior diagnosis of diabetes (type 1 or type 2)
• People who have a current or prior diagnosis of a severe psychiatric condition, such as schizophrenia or bipolar disorder
• People who have a current or prior diagnosis of Myasthenia Gravis
• People who have a known allergy or sensitivity to any ingredient in the active or placebo product used in the trial
• People who work rotating shift work or have irregular sleep patterns
• People who are currently participating in another interventional clinical trial
• People who would be unable to follow the study procedures or attend the remote visit schedule
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period

Important: Always verify eligibility with the trial site directly before applying.