Early Phase 1 Sleep Disorders Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 or older
- People who can read and communicate effectively in English (at US sites), or in English or French (at the Canadian site)
- People who meet the clinical criteria for chronic insomnia
- People with a Body Mass Index (BMI) of 18.5 or higher
Who may not be able to join:
- People under the age of 18
- People who are not able to read and communicate effectively in English (at US sites), or in English or French (at the Canadian site)
- People who are unwilling to share an email address or cell phone number to receive survey links
- People who have ever been diagnosed with a psychotic disorder or bipolar disorder
- People who have a history of severe sleep apnea, or a certain level of breathing interruptions during sleep (AHI of 15 or higher), that has not been treated with an airway pressure device, an oral device, an implanted device, surgery, or weight loss
- People who have started or changed a treatment for sleep apnea in the past three months
- People who do not meet the clinical criteria for chronic insomnia
- People who meet the criteria for narcolepsy or a disorder involving excessive daytime sleepiness
- People who meet the criteria for a circadian rhythm disorder, including those who regularly work night shifts
- People with unstable medical conditions that could make participation unsafe or not practical
- People who have had a fall resulting in hospitalisation, significant injury, or a broken bone in the past 12 months
- People who have had two or more hospitalisations or emergency room visits for ongoing health conditions in the past 12 months
- People currently receiving chemotherapy or radiation therapy for cancer
- People who have ever been diagnosed with or treated for chronic kidney failure, liver insufficiency, or chronic heart failure
- People who are unwilling to avoid other insomnia treatments beyond what is offered in this study
- People with a BMI below 18.5
- People who have experienced substance abuse or dependence in the past 12 months
- People who are currently taking prescription or over-the-counter sleep medications more than twice per week
- People currently using systemic corticosteroid medications or opiate medications
- People who are currently pregnant or breastfeeding, plan to become pregnant, or are unwilling to use birth control for the duration of the study
- People currently taking medications that are not compatible with the drug trazodone (confirm with trial site)
- People found to have sleep apnea or periodic leg movement disorder based on a sleep study
- People with high blood pressure readings at or above certain levels (seated systolic pressure above 180 or diastolic pressure above 110 mmHg) (confirm with trial site)
- People with a specific heart rhythm measurement (corrected QT interval) of 500 ms or higher on an ECG (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Alexandros Vgontzas, MD, Professor, Psychiatry
Phone: 717-531-4123
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I); Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT); Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.