The Efficacy of Modified Olfactory Training for MCI High-Risk Individuals
NCT ID: NCT06821828
Last Updated: 2025-02-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
114 participants
INTERVENTIONAL
2025-03-22
2027-05-22
Brief Summary
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Detailed Description
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Conventional olfactory training (COT) has been shown to improve olfactory function, cognitive abilities, and brain connectivity in healthy elderly individuals, suggesting its potential to enhance neuroplasticity. Preliminary studies indicate that modified olfactory training (MOT) may yield superior outcomes compared to COT, with higher rates of olfactory recovery and improved deposition in the olfactory fissure. However, the efficacy of MOT in delaying or preventing the progression of olfactory dysfunction to MCI remains unclear.
In this study, the investigators planned to recruit 114 patients and divided them into three groups for control group and olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on changes in cognitive function and the comparison of the outcomes of the three groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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the Modified Olfactory Training Group
Participants will use a modified olfactory training device based on expiratory pressure. Four odors will be used: rose, mint, lemon, and clove. Each odorant is sniffed for 10 seconds per session, with a 10-second interval between odors. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of two years.
Modified olfactory training device
Participants will use a modified olfactory training device based on expiratory pressure. The advantages of the improved device are as follows: bi-directional airflow, positive pressure and the function of voice prompts and automatic counting.
the Conventional Training Group
Patients will receive the conventional olfactory training device. Patients had to sniff one odor for approximately 10 seconds and turn to another after a rest of 10 seconds. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of two years.
Conventional olfactory training device
This device involves four brown glass jars (total volume 5 mL) with one of the four odors in each (1mL each, soaked in cotton pads to prevent spilling). The following odors were used: phenyl ethyl alcohol (PEA): rose, menthol: mint, citronellal: lemon, and eugenol: cloves. All jars were labeled with the odor name.
the Control Group
Participants will not receive any olfactory training and will be advised to observe and wait for spontaneous recovery of olfactory function.
No interventions assigned to this group
Interventions
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Modified olfactory training device
Participants will use a modified olfactory training device based on expiratory pressure. The advantages of the improved device are as follows: bi-directional airflow, positive pressure and the function of voice prompts and automatic counting.
Conventional olfactory training device
This device involves four brown glass jars (total volume 5 mL) with one of the four odors in each (1mL each, soaked in cotton pads to prevent spilling). The following odors were used: phenyl ethyl alcohol (PEA): rose, menthol: mint, citronellal: lemon, and eugenol: cloves. All jars were labeled with the odor name.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Idiopathic Olfactory Dysfunction: overall TDI score below 30.75 points using the Sniffin' Sticks test. Without olfactory impairment due to traumatic, sinusitis-related, congenital, toxic/drug-induced causes, post-operative conditions, tumors, or post-upper respiratory infections.
3. Diagnosis of Subjective Cognitive Decline: Montreal Cognitive Assessment (MoCA) score \>24 for middle school level and above, \>19 for elementary school level, and \>13 for illiterate individuals. Amyloid β (Aβ) deposition in the brain (defined as Aβ42 \< 550 ∼ 813 pg/ml)， the higher Formula of Hulstaert (defined as \[(Aβ42/(240 + 1.18 × tau) ≤1\]）, and hippocampus atrophy.
4. Consent: Willingness to sign an informed consent form.
Exclusion Criteria
4\. Recent Medication Use: Exclusion of participants who have taken corticosteroids, antimicrobials, leukotriene antagonists, or antihistamines within the last four weeks.
5\. Inability to Comply with Study Requirements: Based on the researcher's judgment, individuals who are unable to tolerate olfactory function tests and treatment， complete the study or comply with its requirements due to memory or behavioral abnormalities, depression, severe alcohol consumption, or previous non-compliance.
60 Years
90 Years
ALL
No
Sponsors
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Peking University Sixth Hospital
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Dawei Wu
Associate Researcher
Locations
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Dawei Wu
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Lin CY, Tan Y, Zhao D, Wu D. Assessing modified olfactory training to prevent cognitive decline in MCI high-risk individuals: a multicentre randomised controlled trial protocol in Beijing tertiary hospitals. BMJ Open. 2025 Aug 13;15(8):e100880. doi: 10.1136/bmjopen-2025-100880.
Other Identifiers
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9059101
Identifier Type: -
Identifier Source: org_study_id
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