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NCT Number: NCT06607653

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

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

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. MoCA

    Time frame: baseline;15 weeks

  2. Pittsburgh sleep quality index

    Time frame: baseline;15 week

  3. HAMA

    Time frame: baseline;15week

  4. HAMD

    Time frame: baseline;15 week

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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