Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000116729
Ethics application status
Approved
Date submitted
8/12/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Mind Your Nose Trial: The Impact of smell-based memory training (OMT) in older adults
Scientific title
Olfactory-based Memory Training (OMT) in older adults with subjective cognitive decline: A randomised controlled trial
Secondary ID [1] 305956 0
Nil
Universal Trial Number (UTN)
Trial acronym
MYNT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Olfactory decline 324556 0
Subjective cognitive decline 324557 0
Condition category
Condition code
Neurological 322024 322024 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed intervention will be evaluated in a single-blind pilot RCT comparing olfactory-
based memory training (OMT) with visually-based memory training (VMT). Participants will be asked to complete 2 X 10-minute training sessions per day, for a period of 4 weeks (20 training days). Task performance during training sessions will be documented on activity logbooks/scoring sheets supplied to each participant, and they will be further supported by detailed instruction booklets. The instruction booklets will be created specifically for the trial. Participants will also be given a 15-minute demonstration in person by a research assistant and an explanation of the memory training procedure before starting their training regimen. Participants will receive weekly phone calls with a therapist to discuss how they are finding the training, provide encouragement, and monitor progress/ adherence to training. The phone calls will last approximately 10-15 minutes.

OMT will take the form of a memory board game in which 24 tin cans containing 12 pairs of commercially available flavored teas are randomly arranged in 6X4 grid. During each training session, participants will be required to learn the location of pairs of odor stimuli on a game board. In each trial, participants select two tin cans sequentially and sniff their contents. Once a pair of identical odor stimuli are selected, the two tin cans are removed from the game board. The number of trials required to remove all odor pairs from the game board forms the main measure of performance, with fewer trials indicating better performance. Verification of a correct match requires participants to compare barcoded labels affixed to the bottom of each can.
Intervention code [1] 322348 0
Treatment: Other
Comparator / control treatment
The Visual-memory training (VMT) is analogous to the OMT condition, but instead of odors, the 12 pairs of tin cans include foreign language symbols, randomly arranged on the game board, and participants will be required to remove pairs of cans with identical visual symbols. The two training conditions will be identical in all but the content of the tin cans. Participants will receive weekly phone calls with a therapist to discuss how they are finding the training, provide encouragement, and monitor progress/ adherence to training. The phone calls will last approximately 10-15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 329779 0
Global Olfactory Ability assessed through the Sniffin' Sticks Threshold Discrimination and Index (TDI) Scores
Timepoint [1] 329779 0
Immediately post 4-week intervention and at 1-month follow-up
Secondary outcome [1] 403739 0
Visual memory assessed through the Cambridge Neuropsychological Test Automated Battery
(CANTAB) Paired Associate Learning Task
Timepoint [1] 403739 0
Immediately post 4-week intervention and at 1-month follow-up
Secondary outcome [2] 403741 0
Olfactory memory as assessed with the Western Australia Olfactory Memory Test
Timepoint [2] 403741 0
Immediately post 4-week intervention and at 1-month follow-up
Secondary outcome [3] 403743 0
Everyday olfactory ability assessed through a novel, non-standardized measure of everyday olfaction,
Timepoint [3] 403743 0
Immediately post 4-week intervention and at 1-month follow-up
Secondary outcome [4] 403744 0
Subjective memory assessed through the Multifactorial Memory Questionnaire
Timepoint [4] 403744 0
Immediately post 4-week intervention and at 1-month follow-up
Secondary outcome [5] 403745 0
Subjective olfactory ability assessed through a short questionnaire designed for this study.
Timepoint [5] 403745 0
Immediately post 4-week intervention and at 1-month follow-up

Eligibility
Key inclusion criteria
Community-dwelling older people aged 65 years and older; subjective (self-reported) cognitive concerns (with or without objective cognitive impairment).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of dementia; olfactory impairment secondary to a recent viral infection (including covid-19); current smoker; significant neurological or psychiatric condition likely to affect engagement with the training program (e.g., clinically significant depression or anxiety).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher not involved in the study will randomize participants to receive the experimental or control intervention,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequences will be generated by a randomisation software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be reviewed for completeness, and imputation of missing data
using regression will be performed if a small proportion of outcome data (up to 15%) is determined to not be missing at random. Participants’ demographics and baseline data will be compared using parametric and non-parametric tests as appropriate. Linear Mixed Models will be used to evaluate the fixed effect of time, group and their interaction, and the random effect of participants at the post-treatment assessment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310297 0
Charities/Societies/Foundations
Name [1] 310297 0
Alzheimer's Association
Country [1] 310297 0
United States of America
Primary sponsor type
University
Name
The University of Melbourne
Address
151 Barry St. Carlton Victoria 3053
Country
Australia
Secondary sponsor category [1] 311415 0
None
Name [1] 311415 0
NA
Address [1] 311415 0
NA
Country [1] 311415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309960 0
Central Human Research Ethics Committee (CHREC) at the University of Melbourne
Ethics committee address [1] 309960 0
Office of Research Ethics and Integrity, Research, Innovation & Commercialisation Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Ethics committee country [1] 309960 0
Australia
Date submitted for ethics approval [1] 309960 0
07/12/2021
Approval date [1] 309960 0
23/12/2021
Ethics approval number [1] 309960 0
2021-23063-24452-3

Summary
Brief summary
Participation in the Mind Your Nose Trial may be associated with gains in aspects of visual and olfactory based memory. Gains in other outcomes such as mood and psychological wellbeing are also possible. It is hypothesised that olfactory based memory training may lead to gains in both olfactory memory and visual memory. This study will contribute to the current understandings of how we might prevent and treat olfactory and cognitive difficulties in older adults. Findings may have implications for improving functional abilities of older adults, enabling them to lead fulfilling and independent lives. In a very small number of cases, it is possible that participation in the current study will identify a need to refer a participant for more a detailed neuropsychological assessment which may reveal signs of cognitive decline which could turn out to be due to a neurodegenerative condition. It is therefore possible that through participation in this study, earlier detection of cognitive changes will lead to an earlier diagnosis of relevant conditions associated with older age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115998 0
A/Prof Alex Bahar-Fuchs
Address 115998 0
University of Melbourne, 151 Barry St. Carlton Victoria 3053
Country 115998 0
Australia
Phone 115998 0
+61 3 83443357
Fax 115998 0
Email 115998 0
alex.bahar@unimelb.edu.au
Contact person for public queries
Name 115999 0
A/Prof Alex Bahar-Fuchs
Address 115999 0
University of Melbourne, 151 Barry St. Carlton Victoria 3053
Country 115999 0
Australia
Phone 115999 0
+61 3 83443357
Fax 115999 0
Email 115999 0
alex.bahar@unimelb.edu.au
Contact person for scientific queries
Name 116000 0
A/Prof Alex Bahar-Fuchs
Address 116000 0
University of Melbourne, 151 Barry St. Carlton Victoria 3053
Country 116000 0
Australia
Phone 116000 0
+61 3 83443357
Fax 116000 0
Email 116000 0
alex.bahar@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only De-identified individual participant data underlying published results will be shared.
When will data be available (start and end dates)?
Data will be available immediately following publication, if multiple publications are planned to occur then the data will be available immediately following the final publication produced from the study. Currently, no end date has been determined.
Available to whom?
Data may be requested by individuals from research institutes who are interested in the research question. Interested individuals will need to request the data from the principal investigator, who will analyse the request on a case by case basis.
Available for what types of analyses?
If the request for data is granted, then the data is available for any type of analyses.
How or where can data be obtained?
Data can be obtained by contacting the Principal Investigator by email and requesting the data. The request is subject to approval by the Principal Investigator, Dr. Alex Bahar-Fuchs at alex.bahar@unimelb.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14317Informed consent form    383235-(Uploaded-02-12-2021-11-50-57)-Study-related document.docx



Results publications and other study-related documents

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