Phase 2 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 65 or older who are being seen in an outpatient setting (not currently admitted to hospital)
• People who have been diagnosed with insomnia according to a specific set of recognised sleep disorder diagnostic guidelines (confirm with trial site)

Who may not be able to join:

• People who have a known allergy or sensitivity to the medication trazodone
• People who have a type of irregular heartbeat affecting the lower chambers of the heart (such as a condition called torsades de pointes)
• People who have had a heart attack within the past 6 months
• People who are currently taking medications that affect sleep, such as sleeping pills, mirtazapine, quetiapine, corticosteroids, melatonin, or stimulant drugs
• People who have an active and unstable mental health condition
• People who have started or had the dose adjusted on an antidepressant medication within the past 6 months
• People who are currently receiving or planning to receive cognitive-behavioural therapy (a type of talking therapy) during the study period
• People with moderate or severe memory or thinking difficulties, or other cognitive conditions that a doctor determines would prevent participation
• People with Parkinson's disease
• People with a history of priapism (a persistent and painful erection)
• People with a known diagnosis of angle-closure glaucoma (a specific type of eye pressure condition)
• People experiencing restless leg syndrome symptoms more than 3 times per week
• People with a specific heart rhythm measurement (QTc interval) greater than 500 ms on an electrocardiogram (confirm with trial site)
• People with sleep disorders other than insomnia, such as certain abnormal sleep behaviours or other sleep disturbances
• People with severe sleep apnoea (a condition where breathing repeatedly stops during sleep) who are not using a CPAP breathing device
• People who are taking a type of medication called a monoamine oxidase inhibitor (MAOi)
• People who are taking certain medications that strongly affect how the body processes other drugs (known as strong CYP 3A4 inducers or inhibitors) (confirm with trial site)
• People who are currently hospitalised
• People who have had a seizure within the past 6 months
• People with a history of a sudden drop in blood pressure when standing up (orthostatic hypotension)
• People who have experienced an episode of sudden confusion or delirium within the past 6 months
• People who drink more than 14 alcoholic drinks per day, or who use alcohol to help them sleep

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