Phase
Condition
Dementia
Treatment
Suvorexant 20 mg
Placebo
Clinical Study ID
Ages > 65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 65 and older
Undergoing non-cardiac, non-intracranial surgery, any surgical procedure notinvolving the skull, brain, cerebrovascular structures
Scheduled postoperative inpatient overnight stay
Able to give informed consent or has legally authorized representative able to giveinformed consent on their behalf
English-speaking
Exclusion
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 precedingday 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 homebilevel positive airway pressure therapy or home ventilator or other forms ofnoninvasive ventilation
Chronic lung disease requiring home oxygen therapy
History of narcolepsy
Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strongCYP3A inhibitors within 1 week prior to surgery, *See list below
Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strongCYP3A inducers within 1 week prior to surgery, *See list below.
Current or planned administration of digoxin, or is currently experiencing digoxintoxicity
Undergoing surgery that will result in inability to take medications by mouthincluding laryngectomy, tracheostomy, and oral resection/reconstructive surgery
Undergoing surgery that will require postoperative strict bowel rest, includinggastrectomy, esophagectomy, and pancreaticoduodenectomy
Undergoing surgery in an area that will make it unsafe to wear a headband, such asscalp or forehead procedures.
Inappropriate for study inclusion based on the judgement of the principalinvestigator
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
Study Design
Study Description
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
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