NCT06488807 Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment
| NCT ID | NCT06488807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 10th People's Hospital |
| Condition | Perioperative Neurocognitive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 686 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 686 participants in total. It began in 2025-04-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Perioperative neurocognitive disorder (PND) is one of the most common postoperative complications among elderly patients. However, the mechanism and targeted intervention of PND remains unclear. Our previous clinical studies demonstrated the association between olfactory impairment and PND. Moreover, our translational studies showed that anesthesia/surgery induced olfactory impairment and caused cognitive impairment in mice and olfactory enrichment could prevent the anesthesia/surgery-induced cognitive impairment. However, there was no clinical investigation to determine whether olfactory enrichment can mitigate PND in elderly patients. Therefore, we propose determining whether olfactory enrichment can prevent and/or treat PND in elderly patients.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥65 years old. 2. Having a scheduled surgery (≥2 hours, general anesthesia) (e.g., total hip replacement, toal knee replacement, open reduction and internal fixation of hip and lumbar spine). 3. Being able to complete neuropsychological tests, 3D-CAM and CAM-S. 4. Chinese Mandarin as their native language. 5. Edmonton frailty scale (EFS) score ≥ 6. Exclusion Criteria: 1. Having delirium, assessed by 3D-CAM, before surgery. 2. Having a brain tumour, stroke or mental disorders (eg, major depressive disorder or dementia). 3. Participating in other clinical studies at the time of screening. 4. Unwillingness to comply with the protocol or procedures.
Contact & Investigator
Yuan Shen
PRINCIPAL INVESTIGATOR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT06488807 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Perioperative Neurocognitive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06488807 currently recruiting?
Yes, NCT06488807 is actively recruiting participants. Contact the research team at dr.yuanshen@foxmail.com for enrollment information.
Where is the NCT06488807 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06488807 clinical trial?
NCT06488807 is sponsored by Shanghai 10th People's Hospital. The principal investigator is Yuan Shen at Shanghai Mental Health Center. The trial plans to enroll 686 participants.