Sleep Disorders Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 years or older, of any gender
• People who have been formally diagnosed with Insomnia Disorder according to standard psychiatric diagnostic criteria (DSM-5)
• People who have a regular bedtime between 9:00pm and 1:00am, and a regular wake-up time
• People whose insomnia severity scores 15 or higher on a standard insomnia questionnaire (the ISI)
• People whose medications or treatments for insomnia, mental health, or physical health conditions have remained unchanged for at least four weeks before the screening visit, and who are willing to keep them unchanged throughout the study
• People who have not taken any sleep or stress-related supplements for at least four weeks before the screening visit
• People who are willing and able to follow all parts of the study protocol

Who may not be able to join:

• People who have a current diagnosis of a sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, or a circadian rhythm sleep disorder
• People whose depression symptoms are scored as significantly severe (a score above 14 on the PHQ-9 questionnaire) at the screening visit
• People whose anxiety symptoms are scored as significantly severe (a score above 15 on the GAD-7 questionnaire) at the screening visit
• People who are currently pregnant or breastfeeding
• Women who are able to become pregnant and are not using an accepted method of contraception (confirm with trial site for which methods are considered acceptable)
• People whose caffeine intake, in the trial investigator's opinion, is contributing to their insomnia, or who regularly drink caffeine-containing drinks after 6:00pm and are unwilling to stop doing so for the duration of the study
• People with a history of drug or alcohol dependency or misuse within approximately the past two years
• People with a significant ongoing health condition — such as a heart, lung, digestive, kidney, neurological, or psychiatric condition, cancer, or chronic pain — that the investigator believes could affect their safety or interfere with study results
• People who have major surgery scheduled during the study period
• People who are known to be allergic to any ingredients in the study product

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