Phase 2 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:

• You can be male or female, of any race or ethnicity.
• You must be 65 years of age or older and able to sign a consent form yourself.
• You must show no signs of memory or thinking problems based on a standard assessment called the Clinical Dementia Rating (confirm with trial site).
• You must be willing and able to take part in all study activities.

Who may not be able to join:

• You have been told you have, or have symptoms of, restless legs syndrome, narcolepsy, or abnormal sleep behaviors (such as acting out dreams).
• You have a high risk of sleep apnea based on a screening questionnaire, and you do not use a breathing machine (PAP device) at night (confirm with trial site).
• You have untreated sleep apnea with more than 15 breathing interruptions per hour during sleep.
• You have sleep apnea that is not well controlled — either because you don't use your breathing machine enough (less than 4 hours a night on most nights) or still have 10 or more breathing interruptions per hour.
• Your blood test results for a certain protein marker related to brain health fall below a specific level (confirm with trial site).
• You have had a stroke.
• You have a history of kidney problems, specifically if your kidneys are not filtering well enough based on a blood test (confirm with trial site).
• You have a history of liver problems, shown by certain liver enzyme levels being too high on a blood test (confirm with trial site).
• You have HIV/AIDS.
• You have had a problem with drug or alcohol misuse in the past 6 months.
• You regularly drink alcohol 3 or more days a week, where "regularly" means having more than 2 alcoholic drinks within 3 hours of bedtime — though you may still qualify if you agree to reduce your drinking during the study.
• You have a significant medical, behavioral, or mental health condition, or past surgery, that could affect your safety or the study results.
• You have a heart condition requiring medication (except for well-controlled high blood pressure), a lung condition, Type 1 diabetes, a neurological or psychiatric condition requiring medication, untreated depression, or you currently smoke tobacco.
• You take medications that cause drowsiness or that interact with the study drug (lemborexant), unless those medications can be safely stopped.
• Your routine blood test results come back abnormal.
• You currently have thoughts of suicide or self-harm.
• You are not able to speak and understand English.
• You are currently pregnant or breastfeeding.
• The study doctor feels, based on your physical exam, that it would not be appropriate for you to join.
• You have taken part in a clinical trial involving a study drug or device in the 30 days before enrolling in this study.
• You must not join another drug or device study while taking part in this trial.

For an optional part of the study (spinal fluid sample):

• You may not be able to take part in this optional procedure if you take blood thinners, have a bleeding disorder, are allergic to lidocaine or certain skin disinfectants, or have had surgery on your spine or central nervous system (confirm with trial site).

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