Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000095662
Ethics application status
Approved
Date submitted
20/12/2022
Date registered
27/01/2023
Date last updated
27/01/2023
Date data sharing statement initially provided
27/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between nasal-only and combined oro-nasal measures of respiration during rest and swallowing tasks in healthy participants
Scientific title
Comparison between nasal-only and combined oro-nasal measures of respiration during rest and swallowing tasks in healthy participants
Secondary ID [1] 308645 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 328556 0
Condition category
Condition code
Respiratory 325572 325572 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 325591 325591 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will completed at a swallowing research laboratory. The intervention will be administered by a Speech-Language Therapist/PhD candidate with three years' clinical experience. The study will take approximately one hour (allowing 30 mins per method).

The healthy participants will be fitted with two methods for measuring breathing 1) a facemask detecting respiration through the mouth and nose simultaneously and 2) a nasal cannula with an attached nasal probe, to assess nasal airflow. The order in which the two methods are assessed will be counterbalanced between participants. Participants will also be fitted with surface Electromyography (sEMG) adhered to the skin on the chin and collar bone, to examine activity of the swallowing muscles; this will confirm the occurrence of swallowing.

The protocol will be completed twice (once for each assessment method). Participants will be observed during the following tasks: 1) breathing and spontaneous swallowing at rest, 2) single sips of water through a straw, 3) consecutive sips of water through a straw, 4) eating pieces of an Arnotts Salada cracker. Order of tasks will be counterbalanced between participants. There will be a period of at least 5 minutes between the first and second round of tasks, to allow for testing equipment to be changed, and to allow some rest for participants.
Intervention code [1] 325108 0
Diagnosis / Prognosis
Comparator / control treatment
Nasal-only measures of respiration will serve at the comparator.
Control group
Active

Outcomes
Primary outcome [1] 333411 0
Respiratory-swallowing pattern for each swallow, assessed using oral-nasal respiration measures (each swallow will be coded as 1 of 4 options):

Exhale-swallow-exhale (EX-EX)
Inhale-swallow-exhale (IN-EX)
Exhale-swallow-inhale (EX-IN)
Inhale-swallow-inhale (IN-IN)

Measured using a facemask to detect respiration through the mouth and nose simultaneously, in combination with surface electromyography to detect swallowing.
Timepoint [1] 333411 0
On occurrence of each swallow
Secondary outcome [1] 416973 0
Respiratory-swallowing pattern for each swallow, assessed using nasal respiration measures (coded as 1 of 4 options):

Exhale-swallow-exhale (EX-EX)
Inhale-swallow-exhale (IN-EX)
Exhale-swallow-inhale (EX-IN)
Inhale-swallow-inhale (IN-IN)

Measured using a nasal cannula with attached thermistor to detect respiration, alongside surface electromyography to detect swallowing.
Timepoint [1] 416973 0
On occurrence of each swallow

Eligibility
Key inclusion criteria
- Aged 18 or over
- Able to provide informed consent
- Healthy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Current or historical swallowing impairment
- Any respiratory condition

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Counterbalancing of presentation order of respiration assessment method. This will be determined using random allocation of a number e.g., 1 or 2.
Also counterbalancing of presentation order of eating and drinking tasks. This will be determined using random allocation of a number e.g., 1, 2, or 3.
All participants will complete the same tasks within a single session; only order will be adjusted.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be descriptively analysed to determine % of swallows following each breathing-swallowing pattern.
Cohen's Kappa will be used to assess inter-rater and intra-rater reliability.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2023
Actual
Date of last participant enrolment
Anticipated
28/04/2023
Actual
Date of last data collection
Anticipated
28/04/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 25189 0
New Zealand
State/province [1] 25189 0
Canterbury

Funding & Sponsors
Funding source category [1] 312878 0
University
Name [1] 312878 0
University of Canterbury Rose Centre for Stroke Recovery and Research
Country [1] 312878 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury Rose Centre for Stroke Recovery and Research
Address
Level 1, Leinster Chambers
St George's Hospital
249 Papanui Rd, Merivale
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 314554 0
None
Name [1] 314554 0
Address [1] 314554 0
Country [1] 314554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312156 0
University of Canterbury Human Research Ethics Committee
Ethics committee address [1] 312156 0
University of Canterbury
20 Kirkwood Ave
Upper Riccarton
Christchurch 8041
Ethics committee country [1] 312156 0
New Zealand
Date submitted for ethics approval [1] 312156 0
19/10/2022
Approval date [1] 312156 0
14/11/2022
Ethics approval number [1] 312156 0
HREC 2022/73/LR-PS

Summary
Brief summary
Coordination between breathing and swallowing is essential for safe ingestion of food and fluids. Studies typically measure breathing by assessing movement of the chest and ribcage, or by assessing airflow through the nose. In individuals who breathe primarily through the mouth, assessing breathing in this way may not obtain accurate measurements. This study will compare measurements of nasal breathing obtained using a nasal cannula to oral-nasal breathing measures obtained using a facemask, while eating and drinking. It is hypothesised that measures obtained using the oral-nasal facemask will be different to those obtained using the nasal-only cannula.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123674 0
Miss Elizabeth Cross
Address 123674 0
UC Rose Centre
Level 1 Leinster Chambers,
St George's Hospital
249 Papanui Rd, Merivale
Christchurch 8014
Country 123674 0
New Zealand
Phone 123674 0
+64 03 369 2385
Fax 123674 0
Email 123674 0
elizabeth.cross@pg.canterbury.ac.nz
Contact person for public queries
Name 123675 0
Miss Elizabeth Cross
Address 123675 0
UC Rose Centre
Level 1 Leinster Chambers,
St George's Hospital
249 Papanui Rd, Merivale
Christchurch 8014
Country 123675 0
New Zealand
Phone 123675 0
+64 03 369 2385
Fax 123675 0
Email 123675 0
elizabeth.cross@pg.canterbury.ac.nz
Contact person for scientific queries
Name 123676 0
Miss Elizabeth Cross
Address 123676 0
UC Rose Centre
Level 1 Leinster Chambers,
St George's Hospital
249 Papanui Rd, Merivale
Christchurch 8014
Country 123676 0
New Zealand
Phone 123676 0
+64 03 369 2385
Fax 123676 0
Email 123676 0
elizabeth.cross@pg.canterbury.ac.nz

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


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.