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Clinical Trials/NCT03441074
NCT03441074
Completed
Not Applicable

Effects of Odor Enrichment on Delayed Neurocognitive Recovery

Shanghai 10th People's Hospital1 site in 1 country131 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Shanghai 10th People's Hospital
Enrollment
131
Locations
1
Primary Endpoint
Incidence of dNCR
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

To explore whether odor enrichment can reduce the risk of delayed neurocognitive recovery as an intervention strategy.

Detailed Description

Postoperative neurocognitive disorder, one of the most common postoperative complications in older adults, includes acute postoperative delirium, delayed neurocognitive recovery (within the 30 days recovery period, dNCR), and postoperative neurocognitive dysfunction (from expected recovery 30 days to 12 months). Previous studies showed that the incidence of dNCR ranged from 18% to 40% and is mainly characterized by cognitive impairment, which can develop into long-term cognitive impairment, even elevating the risk of Alzheimer's Disease (AD) related dementia and premature mortality. These symptoms can have significant adverse effects on quality of life and may increase the risk of other physical and psychological disorders, potentially impacting social stability. These statistics underscore the importance of early detection and timely intervention in mitigating the long-term effects of dNCR. Despite the significance of dNCR, effective treatment options remain elusive. Based on these insights, previous studies have explored the impact of olfactory enrichment in animal models. Zhang et al. demonstrated that surgery and anesthesia could cause olfactory impairment, which might contribute to dNCR, while suggesting that odor enrichment, a non-pharmacological intervention, could reduce postoperative cognitive impairment in animal models. Olfactory enrichment, also known as olfactory training, is a safe and affordable treatment and may have preventative or supportive effects on olfactory function or cognitive function. Evidence supports its effectiveness in treating olfactory function from various causes and in reducing cognitive impairment. Despite these findings, there is limited research on whether odor enrichment can serve as a mitigating strategy for dNCR among human populations. To address this gap, we conducted a clinical study to investigate whether odor enrichment could mitigate dNCR in geriatric patients and to explore the relationship between olfactory function and dNCR.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2022
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai 10th People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yuan Shen, MD, PhD

Chief of Psychiatry

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • were aged at least 65 years old;
  • were expected a postoperative hospital stay of at least 7 days;
  • had American Society of Anesthesiologist (ASA) class I to II;
  • were native Mandarin speakers;
  • had been referred for a total knee or hip replacement under general anesthesia.

Exclusion Criteria

  • were prior diagnosed of neurologic diseases by the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10);
  • had a history of mental disorders diagnosed using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
  • had a history of illness or surgery with nasal or sinus;
  • caught cold within one week;
  • impaired vision or auditory function which may affect the assessments;
  • were unwilling to comply with the protocol or procedures;
  • did not pass the Mini-mental State Examination (illiterates get less than 18 points, primary school graduates get less than 20 points, secondary school graduates or higher get less than 24 points) .

Outcomes

Primary Outcomes

Incidence of dNCR

Time Frame: 3 days before surgery (baseline) and 7 days after surgery (follow-up)

Participants underwent neuropsychological test battery, which referred to International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) test battery and modified according to the characteristics of Chinese patients. The neuropsychological test battery consisted of the Hopkins Verbal Learning Test-Revised (HVLT-R), Brief Visuo-spatial Memory Test-Revised (BVMT-R), Trails Making Test (TMT), Digital Span Test (DST), HVLT-R Delayed Recall Test, HVLT-R Recognition Discrimination Index, BVMT-R Delayed Recall Test, BVMT-R Recognition Discrimination Index and Verbal Fluency Test (VFT). According to the International Study of Perioperative neurocognitive disorder definition, dNCR was diagnosed by calculating the "Z-score".

Secondary Outcomes

  • Olfactory identification ability(3 days before surgery (baseline) and 7 days after surgery (follow-up))

Study Sites (1)

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