REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

NCT05733286 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00111869
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium in Old Age

Keywords

Sleep

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time (TST) on the First Postoperative Night

  Total sleep time (TST) on first postoperative night that patient received study drug, as measured by electroencephalography (EEG). Total sleep time includes amount of time in sleep during the lights out period (defined between 21:00 and 06:00).

  The first postoperative night that the participants received study drug (D0)

Secondary Outcomes (1)

• Peak Postoperative Delirium Severity Score

  Postoperative Day 0 through Day 5

Other Outcomes (5)

• Postoperative Average Electrographic Total Sleep Time Over the 3-night Recording Period

  Postoperative day 0-2

• Average Postoperative Richards-Campbell Subjective Sleep Quality Scores

  Postoperative days 1-5

• Change In Pupil Diameter Fluctuations From Preoperative Baseline Through Postoperative Day 3

  Preoperative baseline and postoperative days 1-3

Study Arms (2)

Suvorexant Arm

ACTIVE COMPARATOR

Drug: Suvorexant 20 mg

Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Suvorexant 20 mg DRUG

Administer Suvorexant versus placebo every evening for Post-Operative Day (POD) 0,1, \&2

Suvorexant Arm

Placebo DRUG

Administer Suvorexant versus placebo every evening for Post-Operative Day (POD) 0,1, \&2

Placebo Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inmate of correctional facility
• Body mass index\> 40
• Legal blindness
• Unable to perform study related questionnaires and assessments
• Use of outpatient sedating sleep aids \> 2 times per any week in 1 month preceding day of surgery. Sedating sleep aids, \*See list Below.
• History of psychotic disorder, including schizophrenia, schizoaffective disorder, schizophreniform or brief psychotic disorder.
• History of liver failure with documented international normalized ratio (INR) of \>1.2 or with history of hepatic encephalopathy
• 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
• Chronic lung disease requiring home oxygen therapy
• History of narcolepsy
• Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inhibitors within 1 week prior to surgery, \*See list below
• Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inducers within 1 week prior to surgery, \*See list below.
• Current or planned administration of digoxin, or is currently experiencing digoxin toxicity
• Undergoing surgery that will result in inability to take medications by mouth including laryngectomy, tracheostomy, and oral resection/reconstructive surgery
• Undergoing surgery that will require postoperative strict bowel rest, including gastrectomy, esophagectomy, and pancreaticoduodenectomy

Sponsors & Collaborators

• Duke University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Fallon JM, Hashemaghaie M, Peterson CE, Tran D, Wu SR, Valdes JM, Pedicini NM, Adams ME, Soltis M, Mansour W, Wright MC, Raghunathan K, Treggiari MM, Sasannejad C, Devinney MJ. Protocol and design of the REPOSE study: a double-blinded, randomised, placebo-controlled trial to evaluate the efficacy of suvorexant to improve postoperative sleep and reduce delirium severity in older patients undergoing non-cardiac surgery. BMJ Open. 2025 Mar 13;15(3):e091099. doi: 10.1136/bmjopen-2024-091099.

  PMID: 40081971 DERIVED

MeSH Terms

Interventions

suvorexant

Results Point of Contact

• Title: Michael Devinney, MD, PhD
• Organization: Duke University

michael.devinney@duke.edu

919-668-6266

Study Officials

• Michael Devinney Jr, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Dosing labels will be attached to each study drug dose and include pre-printed fields with * Protocol number * Personal ID number * Participant initials * Date * Time
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 17, 2023
• Study Start: June 28, 2023
• Primary Completion: June 25, 2025
• Study Completion: July 7, 2025
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)