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Orexin Receptor Antagonist

Suvorexant for Sleep Disturbance

Phase 4

Waitlist Available

Led By Paul S. Garcia, MD PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 50 years to 90 years old

Patients getting elective surgeries for orthopedic reasons (e.g., hip or knee replacement), abdominal surgery (e.g., hernia repair, renal cancer), urologic or gynecologic surgery, and spine surgery with a projected inpatient stay of 24 hours or longer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 5 post-surgery

Awards & highlights

Study Summary

This trial tests a drug to help people sleep during hospital stays. It is double-blind and randomized to see if the drug is effective.

Who is the study for?

This trial is for people aged 50-90 who are having elective surgeries like hip replacement or hernia repair and have had trouble sleeping at least three times a week over the last three months. It's not for those with severe sleep apnea, chronic pain, certain heart surgeries, mental health issues, dementia, or taking drugs that affect Suvorexant.Check my eligibility

What is being tested?

The study tests if Suvorexant helps with sleep problems after surgery compared to a placebo. Participants will be randomly assigned to either get Suvorexant (20 mg reducing to 10 mg if needed) or placebo pills during their hospital stay.See study design

What are the potential side effects?

Possible side effects of Suvorexant include daytime sleepiness which may lead to a lower dose being administered. Other potential side effects aren't specified but could align with common sleep aid reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old.

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I am scheduled for surgery (like hip replacement or hernia repair) with a hospital stay of at least 24 hours.

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I have had trouble falling asleep or staying asleep at least 3 nights a week for the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 5 post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 5 post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 5 post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total sleep time on day 0 (TST)

Secondary outcome measures

Incidence of Delirium

Longitudinal trend of TST

Rate of attrition

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Suvorexant administrationExperimental Treatment1 Intervention

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). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).

Group II: Placebo administrationPlacebo Group1 Intervention

Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Suvorexant

2016

Completed Phase 4

~2120

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,741 Total Patients Enrolled

1 Trials studying Delirium

325 Patients Enrolled for Delirium

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,461 Total Patients Enrolled

3 Trials studying Delirium

453 Patients Enrolled for Delirium

Paul S. Garcia, MD PhDPrincipal InvestigatorColumbia University

Media Library

Suvorexant (Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05823844 — Phase 4

Delirium Research Study Groups: Suvorexant administration, Placebo administration

Delirium Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT05823844 — Phase 4

Suvorexant (Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05823844 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol include individuals of advanced age?

"This clinical trial has established a minimum age limit of 50 and an upper bound of 90 for potential participants."

Answered by AI

Has Suvorexant been validated by the FDA for therapeutic use?

"There is already approval for Suvorexant's administration, resulting in its safety rating being a 3."

Answered by AI

Are there any remaining opportunities for individuals to become participants in this research?

"According to clinicaltrials.gov, the trial which was initially posted on May 1st 2023 is not presently looking for volunteers. Nonetheless, there are currently 235 other studies actively enrolling participants at this moment in time."

Answered by AI