Improving Sleep to Reduce Delirium in Older Adults After Surgery
Efficacy of Suvorexant to Improve Postoperative Sleep and Reduce Delirium Severity in Older Surgical Patients: A Double-blinded, Randomized, Placebo-controlled Trial
This study is testing if a sleep medication can help older adults sleep better after surgery and reduce the chances of experiencing confusion or delirium.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | Imatinib, Lorlatinib, Pexidartinib |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05733286 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of suvorexant, a drug approved for treating insomnia, in enhancing postoperative sleep and reducing delirium in adults aged 65 and older undergoing non-cardiac surgery. Participants will receive either suvorexant or a placebo for three nights post-surgery while their sleep quality and cognitive function are monitored through various assessments and devices. The study aims to determine if better sleep can lead to less severe delirium, a common complication in older surgical patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older who are scheduled for non-cardiac surgery and will have an overnight hospital stay.
Not a fit: Patients with severe sleep apnea, significant obesity, or a history of psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative recovery and cognitive outcomes for older adults.
How similar studies have performed: While the use of suvorexant for this specific purpose is novel, other studies have shown that improving sleep can positively impact postoperative outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Michael Devinney Jr, MD, PhD — Duke University
- Study coordinator: Alicja Schultz, MBA
- Email: alicja.schultz@duke.edu
- Phone: 919-681-4377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.