COMPLETED

REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

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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

This research study will evaluate the effectiveness of postoperative administration of a drug called suvorexant, to improve postoperative sleep and decrease the severity of delirium (serious confusion) in adults 65 years and older undergoing non-cardiac surgery.

Official Title

Efficacy of Suvorexant to Improve Postoperative Sleep and Reduce Delirium Severity in Older Surgical Patients: A Double-blinded, Randomized, Placebo-controlled Trial

Quick Facts

Study Start:2023-06-28

Study Completion:2025-07-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05733286

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:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 65 and older 2. Undergoing non-cardiac, non-intracranial surgery, any surgical procedure not involving the skull, brain, cerebrovascular structures 3. Scheduled postoperative inpatient overnight stay 4. Able to give informed consent or has legally authorized representative able to give informed consent on their behalf 5. English-speaking	1. Inmate of correctional facility 2. Body mass index\> 40 3. Legal blindness 4. Unable to perform study related questionnaires and assessments 5. Use of outpatient sedating sleep aids \> 2 times per any week in 1 month preceding day of surgery. Sedating sleep aids, \See list Below. 6. History of psychotic disorder, including schizophrenia, schizoaffective disorder, schizophreniform or brief psychotic disorder. 7. History of liver failure with documented international normalized ratio (INR) of \>1.2 or with history of hepatic encephalopathy 8. History of severe sleep apnea or obesity hypoventilation syndrome requiring home bilevel positive airway pressure therapy or home ventilator or other forms of noninvasive ventilation 9. Chronic lung disease requiring home oxygen therapy 10. History of narcolepsy 11. Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inhibitors within 1 week prior to surgery, \See list below 12. Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inducers within 1 week prior to surgery, \*See list below. 13. Current or planned administration of digoxin, or is currently experiencing digoxin toxicity 14. Undergoing surgery that will result in inability to take medications by mouth including laryngectomy, tracheostomy, and oral resection/reconstructive surgery 15. Undergoing surgery that will require postoperative strict bowel rest, including gastrectomy, esophagectomy, and pancreaticoduodenectomy 16. Undergoing surgery in an area that will make it unsafe to wear a headband, such as scalp or forehead procedures. 17. Inappropriate for study inclusion based on the judgement of the principal investigator

Inclusion Criteria

Exclusion Criteria

1. Age 65 and older
2. Undergoing non-cardiac, non-intracranial surgery, any surgical procedure not involving the skull, brain, cerebrovascular structures
3. Scheduled postoperative inpatient overnight stay
4. Able to give informed consent or has legally authorized representative able to give informed consent on their behalf
5. English-speaking

1. Inmate of correctional facility
2. Body mass index\> 40
3. Legal blindness
4. Unable to perform study related questionnaires and assessments
5. Use of outpatient sedating sleep aids \> 2 times per any week in 1 month preceding day of surgery. Sedating sleep aids, \*See list Below.
6. History of psychotic disorder, including schizophrenia, schizoaffective disorder, schizophreniform or brief psychotic disorder.
7. History of liver failure with documented international normalized ratio (INR) of \>1.2 or with history of hepatic encephalopathy
8. History of severe sleep apnea or obesity hypoventilation syndrome requiring home bilevel positive airway pressure therapy or home ventilator or other forms of noninvasive ventilation
9. Chronic lung disease requiring home oxygen therapy
10. History of narcolepsy
11. Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inhibitors within 1 week prior to surgery, \*See list below
12. Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inducers within 1 week prior to surgery, \*See list below.
13. Current or planned administration of digoxin, or is currently experiencing digoxin toxicity
14. Undergoing surgery that will result in inability to take medications by mouth including laryngectomy, tracheostomy, and oral resection/reconstructive surgery
15. Undergoing surgery that will require postoperative strict bowel rest, including gastrectomy, esophagectomy, and pancreaticoduodenectomy
16. Undergoing surgery in an area that will make it unsafe to wear a headband, such as scalp or forehead procedures.
17. Inappropriate for study inclusion based on the judgement of the principal investigator

Contacts and Locations

Principal Investigator

Michael Devinney Jr, MD, PhD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Michael Devinney Jr, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke 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 Date2023-06-28

Study Completion Date2025-07-07

Study Record Updates

Study Start Date2023-06-28

Study Completion Date2025-07-07

Terms related to this study

Keywords Provided by Researchers

Sleep

Additional Relevant MeSH Terms

Delirium in Old Age