Early Phase 1 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:

• People aged 55 years or older.
• People who have been diagnosed with an insomnia disorder, meaning they have had trouble falling asleep, staying asleep, or waking too early at least 3 nights per week for at least 3 months, with at least one daytime problem caused by poor sleep, and a score of 15 or higher on the Insomnia Severity Index (ISI).
• People who have taken 30 minutes or longer to fall asleep on at least 3 nights per week over the past 4 weeks.
• People who are able to give consent electronically.
• People who can read and write fluently in English.

Who may not be able to join:

• People who require a high level of medical care, as determined by a medical officer.
• People with untreated moderate to severe sleep apnoea, identified by a home wrist breathing test (those whose sleep apnoea is being effectively treated may still be considered).
• People with certain other sleep or movement disorders, such as circadian rhythm disorders, narcolepsy, severe restless legs syndrome, or REM sleep behaviour disorder, or those with uncontrolled mental health conditions.
• People with a history of attempted suicide, or who currently have thoughts of suicide (as shown by a score above zero on question 9 of a standard depression questionnaire called the PHQ-9).
• People who score 26 or below on a standard memory and thinking test called the Montreal Cognitive Assessment (MoCA), which indicates measurable cognitive decline.
• People who have done regular shift work, experienced jet lag, or travelled across more than 2 hours of time zones in the week before the trial begins.
• People who are pregnant or breastfeeding. Women who could become pregnant and have a partner who is fertile must have a negative pregnancy blood test at the screening visit and are advised to use contraception for the full duration of the trial.
• People whose participation would raise safety concerns or make it difficult to follow the study procedures, in the judgement of the investigator.
• People who are currently in another research study involving an investigational treatment or device, or who have been in one within the past 4 weeks.
• People who are currently using antipsychotic medications, or specific drugs including bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine, or illegal stimulants.
• People who have regularly used sleep aids — including melatonin, valerian, kava, benzodiazepines, or Z-drugs — or other medications that cause drowsiness (such as sedating antihistamines, tricyclic antidepressants, or antipsychotics) within 14 days or a specific clearance period before the trial starts, whichever is longer.
• People who have regularly used stimulant medications (such as dexamfetamine, lisdexamfetamine, methylphenidate, armodafinil, modafinil, or atomoxetine) within 14 days or a specific clearance period before the trial starts, whichever is longer.
• People who have been taking antidepressants for low mood for less than one year, or who have changed their antidepressant dose or medication within the past year.
• People who have regularly used opioid medications within 14 days or a specific clearance period before the trial starts, whichever is longer.
• People who have used products containing THC or CBD within 14 days before the trial starts.
• People with a history of dependence on alcohol or any other drug within the past two years (alcohol use must also be limited to no more than 2 standard drinks per day during the trial).
• People who regularly use certain medications that affect how the body processes drugs, specifically those known as CYP1A2 inhibitors (such as amiodarone, cimetidine, ciprofloxacin, or fluvoxamine) or CYP1A2 inducers (such as carbamazepine, phenobarbital, rifampin, or tobacco) (confirm with trial site).

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