Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients (NCT06648681) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients
Canada60 participantsStarted 2025-05-01
Plain-language summary
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.
Who can participate
Age range
61 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Admitted to hospital following open cardiac surgery through midline sternotomy
Exclusion Criteria:
* ● Known severe obstructive sleep apnea diagnosed by polysomnography or STOPBANG score \> 5
* Periodic limb movement disorder or restless legs syndrome
* Narcolepsy
* Somnolence (Pasero Opioid Sedation Scale (POSS) \>2)
* Current alcohol or substance use disorder as defined by the DSM-V
* Patient already taking moderate or strong CYP3A inhibitors
* Frequent use of medications for insomnia defined as \>4 days per week.
* Liver failure (Child-Pugh score B or C)
* Renal failure (eGFR\<30 ml/min/1.73 m2)
* Pre-existing delirium (ICDSC score \>3 or CAM/CAM-ICU positive) at time of consent
* BMI\>40 kg/m2
* Known allergy or hypersensitivity to study drug
* Inability to communicate in English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Feasibility
Timeframe: Prior to Surgery, for the duration of the study recruitment period, estimated to be approximately 2 years