NCT06607653Not yet recruitingNot Applicable
The Efficacy of Olfactory Training Intervention on Olfactory and Other Non-motor Symptoms in PD
Anhui Medical University1 site in 1 country40 target enrollmentStarted: September 25, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Olfactory Function Test
Study Overview
Brief Summary
To explore the efficacy of olfactory training on olfactory and other non-motor symptoms in PD.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •5.Good cooperation of patients
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Olfactory training (Device)
No intervention group
No Intervention
There were only pre-test and post-test without any intervention
Outcomes
Primary Outcomes
Olfactory Function Test
Time Frame: baseline;15 weeks
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.
Secondary Outcomes
- MoCA(baseline;15 weeks)
- Pittsburgh sleep quality index(baseline;15 week)
- HAMA(baseline;15week)
- HAMD(baseline;15 week)
Investigators
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University
Study Sites (1)
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