RECRUITING

Efficacy of Suvorexant on Post-operative Sleep Disturbance

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration

Quick Facts

Study Start:2023-05-01
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05823844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 50 years to 90 years old.
  2. * 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.
  3. * Patients experiencing insomnia characterized by difficulties with sleep onset, early morning awakening, and/or sleep maintenance three or more times weekly over a three-month period for eligibility.
  1. * Patients who undergo surgery and then are admitted to intensive care.
  2. * Coronary artery bypass graft (CABG) or other cardiac surgeries.
  3. * Intra-cranial surgery.
  4. * Patients taking more than 60 mg of oxycodone or it's equivalent as outpatient
  5. * Circadian rhythm disorders.
  6. * High score in the Geriatric Depression Scale (GDS)
  7. * Moderate to severe dementia (failed t-MoCa)
  8. * Severe obstructive sleep apnea (OSA) (Apnea-hypopnea index (AHI)\>30 and/or screen high risk)
  9. * Patients receiving Cytochrome P-450 (CYP3) inhibitors or inducers (Inhibitors: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. Inducers: phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids).
  10. * Vulnerable populations (i.e., children, pregnant women).

Contacts and Locations

Study Contact

Paul S. Garcia, MD PhD
CONTACT
212-304-7523
pg2618@cumc.columbia.edu
Oriana Lujan, MD
CONTACT
212-3047523
ol2274@cumc.columbia.edu

Principal Investigator

Paul S. Garcia, MD PhD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building
New York, New York, 10032/10034
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Paul S. Garcia, MD PhD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01
Study Completion Date2025-05

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

  • Sleep Disturbance
  • Insomnia
  • Sleep quality
  • Suvorexant

Additional Relevant MeSH Terms

  • Postoperative Insomnia
  • Postoperative Delirium