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Olfactory Function and Delayed Neurocognitive Recovery

T

Tongji University

Status

Completed

Conditions

Delayed Neurocognitive Recovery

Treatments

Behavioral: Odor Enrichment

Study type

Interventional

Funder types

Other

Identifiers

NCT03441074
dsyy003

Details and patient eligibility

About

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

Full 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.

Enrollment

131 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. were prior diagnosed of neurologic diseases by the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10);
  2. had a history of mental disorders diagnosed using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
  3. had a history of illness or surgery with nasal or sinus;
  4. caught cold within one week;
  5. impaired vision or auditory function which may affect the assessments;
  6. were unwilling to comply with the protocol or procedures;
  7. 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) .

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

131 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Patients randomly assigned to intervention group will get odor enrichment during the perioperative period
Treatment:
Behavioral: Odor Enrichment
Non-intervention Group
No Intervention group
Description:
Patients randomly assigned to non-intervention group will not get any odor enrichment during the perioperative period

Trial contacts and locations

1

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Central trial contact

Zhongyong Shi, MD; Yuan Shen, MD, PhD

Data sourced from clinicaltrials.gov

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