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NCT05823844 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Suvorexant on Post-operative Sleep Disturbance
A Phase 4 study of Postoperative Delirium and Postoperative Insomnia, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT05823844 is a Phase 4 study of Postoperative Delirium and Postoperative Insomnia that is actively recruiting participants, run by Columbia University. The registered enrollment target is 92 participants, below the 168-participant average among 6 other Postoperative Delirium trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05823844, a Phase 4 study of Postoperative Delirium and Postoperative Insomnia, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons. Out of 92 subjects, one experimental group of 46 subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). The other control group of 46 subjects will receive placebo (two tablets) and treatment as usual.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Suvorexant
Study Locations (1)
New York
- NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2025-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05823844
The ClinicalTrials.gov registry entry for NCT05823844 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 168-participant average among 6 other Postoperative Delirium trials with a reported enrollment target (45% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
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.
NCT05823844 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05823844 about?
NCT05823844 is a clinical study titled "Efficacy of Suvorexant on Post-operative Sleep Disturbance". The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons. Out of 92 subjects, one experimental group of 46 subjects will receive 20 mg Suvorexant beginning ...
What is the current status of trial NCT05823844?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 92 participants. The study started on 2023-05-01. Estimated completion is 2025-05.
What conditions does trial NCT05823844 study?
This clinical trial studies the following conditions: Postoperative Delirium, Postoperative Insomnia.
What interventions are being tested in trial NCT05823844?
The interventions under investigation include: Placebo (DRUG), Suvorexant (DRUG).
Who is sponsoring clinical trial NCT05823844?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05823844 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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