REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant
Delirium in Old Age
Bottom Line
View on ClinicalTrials.gov: NCT05733286 ↗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
| Outcome | Result | p-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
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
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.