Olfactory Function and Delayed Neurocognitive Recovery

NCT03441074 | Completed DMC

• 1 other identifier: dsyy003
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Delayed Neurocognitive Recovery

Outcome Measures

Primary Outcomes (1)

• Incidence of dNCR

  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".

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

Secondary Outcomes (1)

• Olfactory identification ability

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients randomly assigned to intervention group will get odor enrichment during the perioperative period

Behavioral: Odor Enrichment

Non-intervention Group

NO INTERVENTION

Patients randomly assigned to non-intervention group will not get any odor enrichment during the perioperative period

Interventions

Odor Enrichment BEHAVIORAL

Patients in intervention group will get odor enrichment during perioperative period (3 days before the surgery and 7 days after the surgery). Odor-enriched participants were exposed daily for 24 hours to different aromatic fragrances (phenyl ethyl alcohol - rose; eucalyptol - eucalyptus; citronellal - lemon; eugenol - cloves) referred to previous studies. Odors were changed for each subject after 24 hours. According to previous studies, 10 drops of the 100% essential oil (0.5 ml) were dropped on a fabric which was placed in tea bags hanging at the hospital bedside.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) .

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (4)

• Kim MS, Yoon JH, Kim HJ, Yong SW, Hong JM. Olfactory dysfunction is related to postoperative delirium in Parkinson's disease. J Neural Transm (Vienna). 2016 Jun;123(6):589-94. doi: 10.1007/s00702-016-1555-0. Epub 2016 Apr 20.

  PMID: 27098668 BACKGROUND

• Brown CH 4th, Morrissey C, Ono M, Yenokyan G, Selnes OA, Walston J, Max L, LaFlam A, Neufeld K, Gottesman RF, Hogue CW. Impaired olfaction and risk of delirium or cognitive decline after cardiac surgery. J Am Geriatr Soc. 2015 Jan;63(1):16-23. doi: 10.1111/jgs.13198.

  PMID: 25597555 BACKGROUND

• Zhang C, Han Y, Liu X, Tan H, Dong Y, Zhang Y, Liang F, Zheng H, Crosby G, Culley DJ, Marcantonio ER, Shen Y, Cao JL, Xie Z. Odor Enrichment Attenuates the Anesthesia/Surgery-induced Cognitive Impairment. Ann Surg. 2023 Jun 1;277(6):e1387-e1396. doi: 10.1097/SLA.0000000000005599. Epub 2022 Jul 18.

  PMID: 35848747 BACKGROUND

• Pieniak M, Oleszkiewicz A, Avaro V, Calegari F, Hummel T. Olfactory training - Thirteen years of research reviewed. Neurosci Biobehav Rev. 2022 Oct;141:104853. doi: 10.1016/j.neubiorev.2022.104853. Epub 2022 Sep 5.

  PMID: 36064146 BACKGROUND

Study Officials

• Yuan Shen

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychiatry

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)