The Efficacy of Olfactory Training Intervention on Olfactory and Other Non-motor Symptoms in PD

NCT06607653 | Not Yet Recruiting

• 1 other identifier: AHMU-PD-OT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy of olfactory training on olfactory and other non-motor symptoms in PD.

Conditions

Parkinson Disease; Olfactory Disorder; Olfactory Training

Keywords

Parkinson Disease; Olfactory Disorder; Olfactory training

Outcome Measures

Primary Outcomes (1)

• Olfactory Function Test

  The olfactory test developed by the Institute of Psychology, Chinese Academy of Sciences was used to evaluate the olfactory ability, including threshold, discrimination, and recognition.

  baseline;15 weeks

Secondary Outcomes (4)

• MoCA

  baseline;15 weeks

• Pittsburgh sleep quality index

  baseline;15 week

• HAMA

  baseline;15week

• HAMD

  baseline;15 week

Study Arms (2)

OT grroup

EXPERIMENTAL

Olfactory training used repeated stimulation of different olfactory substances at high concentrations, combined with odor association and odor identification training, twice in the morning and evening, each time for 5 minutes, for 15 weeks.

Device: Olfactory training

No intervention group

NO INTERVENTION

There were only pre-test and post-test without any intervention

Interventions

Olfactory training DEVICE

Olfactory training used repeated stimulation of different olfactory substances at high concentrations, combined with odor association and odor identification training, twice in the morning and evening, each time for 5 minutes, for 15 weeks.

OT grroup

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PD was diagnosed according to the criteria of Movement Disorders and Parkinson Disease Group of Chinese Society of Neurology of Chinese Medical Association.
• Olfactory score was 1 standard deviation lower than the corresponding age norm;
• no medication plan in the past four weeks or no change in medication plan in the past four weeks, which can be maintained until the end of the experiment; 4.40-75 years old, with normal vision, hearing and language understanding and expression ability;
• Good cooperation of patients

You may not qualify if:

• Parkinson\'s syndrome and Parkinson\'s plus syndrome caused by cerebrovascular disease, encephalitis, trauma, drugs, etc.;
• Neuropsychiatric diseases that may affect the sense of smell, such as depression, anxiety, schizophrenia, etc.;
• History of nasal disease or surgery, such as rhinitis, sinusitis, nasal septum deviation, etc. Upper respiratory tract infection in the past 3 weeks;
• Long-term smoking and occupations that inhale chemical irritants for a long time.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: September 25, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 10, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)