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NCT07217912 · ClinicalTrials.gov registry record · Phase 2
Daridorexant to Prevent Post-cardiotomy Delirium
A Phase 2 study of Postoperative Delirium and Postoperative Cognitive Decline, sponsored by University of Rochester.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT07217912: Recruiting Phase 2 study of Postoperative Delirium and Postoperative Cognitive Decline, sponsored by University of Rochester.
NCT07217912 is a Phase 2 study of Postoperative Delirium and Postoperative Cognitive Decline that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 80 participants, below the 173-participant average among 8 other Postoperative Delirium trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07217912, a Phase 2 study of Postoperative Delirium and Postoperative Cognitive Decline, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Daridorexant 50 mg
Study Locations (1)
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-10-14 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 2 |
What NCT07217912 shows while recruiting
NCT07217912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 173-participant average among 8 other Postoperative Delirium trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Postoperative Delirium appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07217912 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07217912 about?
NCT07217912 is a clinical study titled "Daridorexant to Prevent Post-cardiotomy Delirium". 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), t...
What is the current status of trial NCT07217912?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2025-10-14. Estimated completion is 2027-11-01.
What conditions does trial NCT07217912 study?
This clinical trial studies the following conditions: Postoperative Delirium, Postoperative Cognitive Decline.
What interventions are being tested in trial NCT07217912?
The interventions under investigation include: Placebo (OTHER), Daridorexant 50 mg (DRUG).
Who is sponsoring clinical trial NCT07217912?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217912 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07217912's enrollment target sits among peer trials
80 8th of 8 higher than 1 of 8 other Postoperative Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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