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Trial registered on ANZCTR


Registration number
ACTRN12619001742167
Ethics application status
Approved
Date submitted
29/11/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Spontaneous Swallowing Reduced in Parkinson's Compared to Healthy Controls?
Scientific title
Is Spontaneous Swallowing Reduced in Parkinson's Compared to Healthy Controls?
Secondary ID [1] 299296 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 314424 0
Condition category
Condition code
Neurological 312766 312766 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A matched case design will be used for this study. Thirty people with Parkinson's and thirty controls will be recruited.

The primary independent variable will be PD diagnosis (y/n) and the primary dependent variable will be frequency of spontaneous salivary swallowing (swallows/minute).

Spontaneous swallowing is measured in a single session using audio recordings of swallowing via an electret microphone secured to the participant's neck. Participants are set up to use a tablet-based distraction task and left alone in a quiet, temperature-controlled room for 30 minutes.

The assessor is blinded to participant group. They use waveform and spectrogram information and unrestricted playback in Audacity to count the number of swallows. The first five minutes of the sample is not analysed, in order to ensure participants were sufficiently distracted.
Intervention code [1] 315570 0
Not applicable
Comparator / control treatment
The same spontaneous swallowing measures will be taken from controls.

Controls will be selected from rehabilitation patients, age and gender matched to each case. The literature on age differences in swallowing rates is contradictory but a few papers indicate a difference between young adults (college students) and older adults; therefore, a control who is ± 2 years from the case’s age will be assumed to be sufficiently matched. Rehabilitation patients are sought for convenience of recruitment, but will provide suitable controls because:
• Inpatients at rehabilitation are medically stable and preparing for discharge
• Cases and controls are both rehabilitation patients, and therefore will be similarly matched across health and function
• The exclusion criteria for medical history below should eliminate possible alternative causes of swallowing rate differences
Control group
Active

Outcomes
Primary outcome [1] 321392 0
Difference in frequency of spontaneous swallowing (swallows/min) between groups.
Frequency of spontaneous swallowing is assessed using audio recordings of swallows via electret microphone attached to the neck and analysed manually using computer software for playback.
Timepoint [1] 321392 0
Time of observation
Secondary outcome [1] 374850 0
Mean number of salvo swallows (>3 consecutive swallows) in Parkinson's Disease group.
Salvo swallows are defined as 3 or more consecutive swallows and will be manually identified from the audio recordings of spontaneous swallowing, using computer software for playback.
Timepoint [1] 374850 0
Time of observation
Secondary outcome [2] 374851 0
Facial Masking severity - assessed using Movement Disoder Society Unified Parkinson's Disease Rating Scale (item 3.2) rated by the assessor.
Timepoint [2] 374851 0
Time of observation
Secondary outcome [3] 377671 0
Dysphagia - assessed using the Clinical Assessment of Dysphagia in Neurodegeneration (CADN).
Timepoint [3] 377671 0
Time of observation
Secondary outcome [4] 377672 0
Dysarthria - assessed from recordings of several speech tasks including reading 'The Rainbow Passage', stating the days of the week, maximum phonation of the vowel /a/, and producing alternating and sequential motion rates (/p/, /t/, /k/, /pataka/). The assessor conducts recordings during the single assessment visit using professional speech recording equipment.
Timepoint [4] 377672 0
Time of observation
Secondary outcome [5] 377673 0
Disease severity - assessed using the Modified Hoehn and Yahr Scale, rated by staff conducting screening and consent.
Timepoint [5] 377673 0
Time of observation
Secondary outcome [6] 377674 0
Postural changes - assessed using the Movement Disoder Society Unified Parkinson's Disease Rating Scale (item 3.13) rated by the assessor.
Timepoint [6] 377674 0
Time of observation
Secondary outcome [7] 377675 0
Drooling severity - assessed using the Radboud Oral Motor Inventory for PD – saliva subset, completed by the participant
Timepoint [7] 377675 0
Time of observation

Eligibility
Key inclusion criteria
• Aged over 18 years [All participants]
• Diagnosis of Idiopathic PD as per neurologist [Parkinson's participants only]
• Hoehn & Yahr Parkinson’s severity >1 [Parkinson's participants only]
• If taking saliva management medication, cognitively able to consent to cease for three days prior [Parkinson's participants only]
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• History of stroke
• History of head and neck cancer
• History of neurological conditions (other than PD)
• History of surgery or trauma impacting the upper aerodigestive tract
• Pathological oral condition as observed on examination by Speech Pathologist
• Allergy to adhesives
• Deep Brain Stimulator
• Botox to salivary glands past 6 months

Study design
Purpose
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Based on a population mean swallowing frequency of 1.18 (SD 0.47) (Pehlivan et al, 1996), to find a difference in spontaneous swallowing frequency of 0.38 with an alpha of 0.05 and a power of 0.80, a minimum of 26 participants in each group is necessary.

The assessor will re-assess a random 10% sample at least two weeks after the initial assessment to examine intra-rater reliability. A second assessor will analyse a random 10% sample to examine inter-rater reliability.

A biostatistician will be employed to complete statistical analysis.
Inter-rater reliability will be analysed using ICC (2, 1), in which the same raters assess the same subjects, each rating is considered individually, and both rathers and subjects are assumed to be representative of their respective populations. Intra-rater reliability will be assessed with ICC (3,1) which also considers each rating individually but does not assume that a rater is representative of other raters.
Data for H1-H3 will each be checked for normality visually using histograms and confirmed with Shapiro-Wilks tests. If data are not normally distributed, logarithmic or square root transformations may be used as advised by the statistician to meet the parametric testing requirements.
For H1 and H2, the two groups will be compared using a two-sample t-test (p = .05).
H3 will be examined using a 2-sample equivalence test with p = 0.05.
For H4, the relationships between each factor and the drooling severity will be assessed using Spearman’s correlation analysis (p = .05).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/12/2019
Actual
Date of last participant enrolment
Anticipated
20/12/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14792 0
Cabrini Hopetoun Rehabilitation Hospital - Elsternwick
Recruitment postcode(s) [1] 28034 0
3185 - Elsternwick

Funding & Sponsors
Funding source category [1] 303820 0
Charities/Societies/Foundations
Name [1] 303820 0
Cabrini Foundation
Country [1] 303820 0
Australia
Primary sponsor type
Individual
Name
John E. Pierce
Address
Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun Street
Elsternwick VIC3185
Country
Australia
Secondary sponsor category [1] 303945 0
Individual
Name [1] 303945 0
Adam Vogel
Address [1] 303945 0
University of Melbourne
550 Swanston St, Carlton VIC 3053
Country [1] 303945 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304334 0
Monash Health
Ethics committee address [1] 304334 0
Ethics committee country [1] 304334 0
Australia
Date submitted for ethics approval [1] 304334 0
16/07/2019
Approval date [1] 304334 0
17/10/2019
Ethics approval number [1] 304334 0
RES-19-0000-552A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96582 0
Mr John E. Pierce
Address 96582 0
Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun St
Elsternwick VIC3185
Country 96582 0
Australia
Phone 96582 0
+61 3 9508 5132
Fax 96582 0
Email 96582 0
[email protected]
Contact person for public queries
Name 96583 0
John E. Pierce
Address 96583 0
Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun St
Elsternwick VIC3185
Country 96583 0
Australia
Phone 96583 0
+61 3 9508 5132
Fax 96583 0
Email 96583 0
[email protected]
Contact person for scientific queries
Name 96584 0
John E. Pierce
Address 96584 0
Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun St
Elsternwick VIC3185
Country 96584 0
Australia
Phone 96584 0
+61 3 9508 5132
Fax 96584 0
Email 96584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate group data will be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.