Daridorexant to Prevent Post-cardiotomy Delirium
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Rochester
About this trial
The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting.
Participants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 60 yrs;
having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
can provide consent;
able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);
Disqualifiers
Prior cardiotomy
Infectious endocarditis
Emergency surgery
Delirium at baseline (positive 3D-CAM)
Trial design
Design model
Parallel
Treatments tested in this trial
Daridorexant 50 mg
DrugAdministered consistent with labeling from the US Food and Drug Administration.
Placebo
Other interventionIdentical appearing to daridorexant
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: daridorexantExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Delirium incidence and severity
Participants will be assessed on postoperative days 1-3 using the Delirium Rating Scale, Revised-98 (DRS-R98; range 0-39; higher scores indicate greater severity of delirium symptoms) and 3-minute Diagnostic interview for the Confusion Assessment Method (3D-CAM; 22 dichotomous items used to inform delirium status). Delirium diagnosis is defined per Diagnostic and Manual of Mental Disorders, 5th Edition, Text Revision, and its severity defined as the sum of DRS-R98 score on postoperative days 1-3.
Time frame
Postoperative Days 1-3Secondary outcomes
1
Postoperative sleep quality
Participants will complete Richards-Campbell Sleep Questionnaire on postoperative days 1-3. This scale includes 6 items (sleep-related domains), each scored using a visual analog scale, ranging from 0 to 100. The total score represents the mean of the first five domain scores. Higher scores indicate better subjective sleep quality.
Time frame
Postoperative Nights 1-3Sponsors and contacts
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Source ClinicalTrials.gov