Early Phase 1 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 55 years or older.
• People who have been diagnosed with insomnia disorder, meaning they have trouble falling asleep, staying asleep, or wake up too early at least 3 nights per week, for at least 3 months, and this affects their daytime functioning — and who score 15 or higher on the Insomnia Severity Index (ISI) questionnaire.
• People who have spent 30 minutes or more trying 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 are fluent in reading and writing English.

Who may not be able to join:

• People who are highly dependent on medical care, as determined by a medical officer.
• People who have untreated moderate-to-severe sleep apnoea (a breathing-related sleep condition), identified through a home wrist-based oxygen test — though people whose sleep apnoea is being effectively treated and who also have insomnia may still be considered.
• People who have circadian rhythm disorders, narcolepsy, severe restless legs syndrome, REM sleep behaviour disorder, or psychiatric conditions that are not well managed.
• People who have a history of attempted suicide, or who are currently experiencing thoughts of suicide (confirm with trial site).
• People who score 26 or below on a standardised memory and thinking assessment called the Montreal Cognitive Assessment (MoCA), which may indicate cognitive decline.
• People who work regular night shifts, or who have experienced significant time zone changes (more than 2 hours difference) in the week before joining the trial.
• People who are pregnant or breastfeeding. Women of childbearing age with a fertile partner would need to have a negative pregnancy blood test at screening, and would be advised to use contraception for the duration of the study.
• People with any other condition that the trial investigator considers a safety concern or that would make following the trial procedures difficult.
• People who are currently in, or who have taken part in, another clinical research study involving an experimental treatment within the past 4 weeks.
• People currently using anti-psychotic medications, or specific drugs including bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine, or illicit stimulants.
• People who have regularly used sleep aids in the past 14 days (or longer, depending on the medication), including melatonin, valerian, kava, benzodiazepines, Z-drugs, or other medications that cause sedation such as certain antihistamines, tricyclic antidepressants, or antipsychotics.
• People who have regularly used stimulant medications (such as those used for ADHD or wakefulness) in the past 14 days or longer, depending on the medication (confirm with trial site for specific medications).
• People who have been taking antidepressants for low mood for less than one year, or who have had a change in their antidepressant type or dose within the past year.
• People who have regularly used opioid medications within the past 14 days or longer, depending on the medication.
• People who have used products containing THC or CBD (cannabis-derived substances) within the past 14 days.
• People with a history of alcohol or drug dependence within the past two years. Alcohol consumption during the trial would need to be limited to no more than 2 standard drinks per day.
• People who regularly use certain medications that affect how the liver processes drugs (specifically CYP1A2 inhibitors or inducers — confirm with trial site for specific medications), including tobacco smokers.

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