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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: Recruiting Phase 4 study of Postoperative Delirium and Postoperative Insomnia, sponsored by Columbia University.

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 171-participant average among 8 other Postoperative Delirium trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Placebo
  • DRUG Suvorexant

Study Locations (1)

New York

  • NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building - New York

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2023-05-01
Est. Completion 2025-05
Phase Phase 4
Columbia University

958 total trials

What NCT05823844 shows while recruiting

NCT05823844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 171-participant average among 8 other Postoperative Delirium trials with a reported enrollment target (46% 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.

NCT05823844 reports a single indexed study location in 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.

Similar trials for Postoperative Delirium

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05823844's enrollment target sits among peer trials

92 7th of 8 higher than 2 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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Source: ClinicalTrials.gov NCT05823844, the US trial registry maintained by the National Library of Medicine. NCT05823844 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.