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Phase 2 N=128 Randomized Triple-blind Treatment

REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

Delirium in Old Age

Enrolled (actual)
128
Serious AEs
14.6%
Results posted
Jan 2026
Primary outcome: Primary: Total Sleep Time (TST) on the First Postoperative Night — 3.91; 3.84 hours — p=0.853

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Suvorexant 20 mg (Drug); Placebo (Drug)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Duke University
Primary completion
Jun 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Sleep Time (TST) on the First Postoperative Night
3.91; 3.84 0.853
SECONDARY
Peak Postoperative Delirium Severity Score
2; 1 0.340

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Undergoing surgery in an area that will make it unsafe to wear a headband, such as scalp or forehead procedures.
  • Inappropriate for study inclusion based on the judgement of the principal investigator

Exclusionary Medications:

Moderate CYP3A inhibitors: Amprenavir, Aprepitant, Atazanavir, Ciprofloxacin, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Imatinib, Verapamil, grapefruit juice.

Strong CYP3A inhibitors: Ketoconazole, Itraconazole, Posaconazole, Clarithromycin, Nefazodone, Ritonavir, Saquinavir, Nelfinavir, Indinavir, Boceprevir, Telaprevir, Telithromycin, Conivaptan

Moderate/Strong CYP3A inducers: Apalutamide, Carbamazepine, Enzalutamide, Ivosidenib, lumacaftor, Mitotane, Phenytoin, Rifampin, St. John's wort, Bosentan, Cenobamate, Dabrafenib, Efavirenz, Etravirine, Lorlatinib, Pexidartinib, Phenobarbital, Primidone, Sotorasib.

Sedating sleep aids: Mirtazapine, Trazodone, Flurazepam, Temazepam, Triazolam, Estazolam, Quazepam, Clonazepam, Lorazepam, Midazolam, Alprazolam, Diazepam, Zolpidem, Zaleplon, Eszopiclone, Diphenhydramine, Doxylamine, Hydroxyzine, Suvorexant, Doxepin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05733286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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