Parkinson DiseaseNCT06607653
The Efficacy of Olfactory Training Intervention on Olfactory and Other Non-motor Symptoms in PD
A study testing Olfactory training in people with Parkinson Disease and Olfactory Disorder, run by Anhui Medical University at 1 site in China.
Trial summary
To explore the efficacy of olfactory training on olfactory and other non-motor symptoms in PD. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease, Olfactory Disorder, Olfactory Training
- What is being tested?
- Olfactory training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2024to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui
Panpan Hu, 13515602285, hpppanda9@126.com
About this study
To explore the efficacy of olfactory training on olfactory and other non-motor symptoms in PD.
- Conditions
- Parkinson Disease, Olfactory Disorder, Olfactory Training
- Being tested
- Olfactory training
- Keywords
- Parkinson Disease, Olfactory Disorder, Olfactory training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Olfactory training |
| No intervention group | No intervention | There were only pre-test and post-test without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline;15 weeks
Secondary outcomes (4)
MoCA
Measured: baseline;15 weeks
Pittsburgh sleep quality index
Measured: baseline;15 week
HAMA
Measured: baseline;15week
HAMD
Measured: baseline;15 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start25 Sep 2024 (estimated)
- Primary completion10 Mar 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607653
- Sponsor's protocol ID
- AHMU-PD-OT
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Olfactory Training Intervention on Olfactory and Other Non-motor Symptoms in PD
- ClinicalTrials.gov ID
- NCT06607653
- Acronym / sponsor ID
- AHMU-PD-OT
- Conditions
- Parkinson Disease, Olfactory Disorder, Olfactory Training
- Keywords
- Parkinson Disease, Olfactory Disorder, Olfactory training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (estimated)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy of olfactory training on olfactory and other non-motor symptoms in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT grroup | Experimental | Device: Olfactory trainingOlfactory 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. |
| No intervention group | No intervention | –There were only pre-test and post-test without any intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory trainingOlfactory 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 | OT grroup |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory training in people with Parkinson Disease and Olfactory Disorder, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory Function Test (time frame: baseline;15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.