Not yet recruiting NCT06607653
The Efficacy of Olfactory Training Intervention on Olfactory and Other Non-motor Symptoms in PD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olfactory training.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Olfactory Disorder, Olfactory Training. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To explore the efficacy of olfactory training on olfactory and other non-motor symptoms in PD.
Interventions
- Device Olfactory training
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.
Primary outcome measures
- Olfactory Function Test [Time frame: baseline;15 weeks]
Secondary outcome measures (4)
- MoCA [Time frame: baseline;15 weeks]
- Pittsburgh sleep quality index [Time frame: baseline;15 week]
- HAMA [Time frame: baseline;15week]
- HAMD [Time frame: baseline;15 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cognitive Neuropsychology Lab Anhui Medical University — Hefei
Identifiers
NCT: NCT06607653 · AHMU-PD-OT