Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001087549p
Ethics application status
Submitted, not yet approved
Date submitted
17/05/2023
Date registered
9/09/2024
Date last updated
9/09/2024
Date data sharing statement initially provided
9/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility and acceptability of Good Air Nosebuds: a wearable nasal device in older adults attending a gymnasium.
Scientific title
Assessing the feasibility and acceptability of Goodair Nosebuds, a nasal airflow oscillation device in older adults: a pilot study in a gymnasium setting.
Secondary ID [1] 309669 0
Nil known
Universal Trial Number (UTN)
U1111-1292-5361
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 330018 0
inadequate sleep 330027 0
poor quality of life 330028 0
self-perceived stress 330029 0
poor sleep satisfaction 335031 0
Condition category
Condition code
Public Health 326935 326935 0 0
Other public health
Physical Medicine / Rehabilitation 327217 327217 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Description: This study examines the feasibility of incorporating the Goodair Nosebuds, a nasal airflow oscillation device, into the daily routine of older adults attending a gym facility.

Materials Provided: Participants will receive a Goodair Nosebuds device and a user guide that covers usage, maintenance, and safety procedures. Gym staff will also be briefed about the study.

Study Procedures: Over an 8-week period, participants are asked to use the device twice daily for 10-minute sessions. Participants may use the device at their convenience, although they are encouraged to use it after morning and afternoon meals for easier recall. Initial usage should be while at rest, progressing to usage during activities like walking or gym sessions. Participants will be free to undertake any gym exercises they wish, with no specific regimens or programs required. A demonstration will be provided at the onset of the study in the gym, and gym staff will make observations throughout the eight weeks when participants visiti the gym.

Intervention Delivery: Members of the research team will provide the initial demonstration. Participants will then self-administer the intervention.

Mode of Delivery: Initial introduction and instructions will be provided face-to-face at the gym. Follow-up interactions will be conducted either at the gym or via telephone.

Duration and Frequency: The device will be used for 8 weeks, twice daily for 10-minute sessions. Gym staff will provide observational feedback at the conclusion of this period.

Location: The intervention is flexible and can take place at any location convenient for the participant, such as their home, a gym, or any other setting where they feel comfortable using the device.

Personalization: All participants will follow the same guidelines for device usage.

Adherence Measures: Participant adherence will be monitored through check-ins and gym staff observations. To support consistent use, reminders and encouragement will be provided by the research team and gym staff.

Feasibility Evaluation: The study's success will be gauged based on rates of participant adherence, gym staff observations, and initial data on exercise capacity and well-being among the older adult participants.
Intervention code [1] 326111 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334769 0
Feasibility: Feasibility of the study will be assessed through a composite primary coutcome comprising the following measures:
Recruitment rates: Assessed by auditing study enrolment logs to track the number of participants successfully recruited into the study.
Participant adherence to the intervention: Monitored through regular check-ins, gym staff observations, and automated usage data recorded by the device. This usage data is accessed through a server to track the frequency and duration of device use.
Retention rates: Assessing by auditing study withdrawal logs to monitor the number of participants who complete the study versus those who withdraw.
Qualitative feedback: Gathered through semi-structured, one-on-one face to face interviews conducted by a member of the research team at the end of the study. These interviews will explore participants' experiences, challenges, and perceptions of the intervention.
Timepoint [1] 334769 0
Data for recruitment rates will be collected at the end of the recruitment period (anticipated to be 2 months from the start of the study). Participant adherence to the intervention will be assessed weekly throughout the intervention period (8 weeks). Retention rates will be calculated at the end of the study (4 months from the start of the study). Qualitative interviews will be gathered via interviews conducted within 2 weeks following the end of the study.
Secondary outcome [1] 422024 0
Quality of Life as measured by the 19-item Control, Autonomy, Self-realisation, and Pleasure (CASP-19) tool. This instrument assesses the degree to which human needs are satisfied in four life domains for older adults, distinguishing overall subjective quality of life from influencing contextual factors. The rating scales for each item range from 'Never' to 'Often', and the total score ranges from 0 to 57, with lower scores indicating poorer quality of life.
Timepoint [1] 422024 0
at baseline and after 8 weeks of intervention
Secondary outcome [2] 422025 0
Perceived Stress Levels, assessed using Cohen's Perceived Stress Scale (PSS). This self-report survey evaluates the individual's perception of stress over the past 4 weeks. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress levels.
Timepoint [2] 422025 0
at baseline and after 8 weeks of intervention
Secondary outcome [3] 422028 0
Participation in Leisure-time Physical Activity as measured by the Active Australia Survey. This instrument evaluates participation in various types of physical activity. It has been tested in older adults and found to be acceptable for use in this population.
Timepoint [3] 422028 0
at baseline and after 8 weeks of intervention.
Secondary outcome [4] 422029 0
Sleep Quality, evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI measures seven components of sleep, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Timepoint [4] 422029 0
at baseline and after 8 weeks of intervention.
Secondary outcome [5] 422030 0
blood pressure will be measured using sphygmomanometer
Timepoint [5] 422030 0
at baseline and after 8 weeks of intervention
Secondary outcome [6] 422031 0
heart rate will be measured using a pulse oximeter.
Timepoint [6] 422031 0
at baseline and after 8 weeks of intervention
Secondary outcome [7] 428379 0
Awareness of Public Health Messages on Physical Activity, as measured by the Active Australia Survey. This instrument evaluates knowledge of current public health messages about the benefits of physical activity. It has been tested in older adults and found to be acceptable for use in this population.
Timepoint [7] 428379 0
at baseline and after 8 weeks of intervention.
Secondary outcome [8] 428400 0
Observational Insights:This outcome involves assessing participants' and gym staff's observations regarding adherence, challenges, and experiences with integrating 'Goodair Nosebuds' into the participants' daily routines.
Interviews: Qualitative feedback will be gathered through semi-structured, one-on-one face-to-face interviews conducted by a member of the research team. These interviews will explore individual experiences, challenges, and observations related to the intervention.
If individual interviews are not feasible, focus groups will be conducted as an alternative. These focus groups will consist of 4-6 participants and will be facilitated by a trained member of the research team. The focus groups will encourage discussion among participants and/or gym staff about their collective experiences with the intervention.
Timepoint [8] 428400 0
immediately after the 8 week intervention period.
Secondary outcome [9] 428401 0
Safety Standpoints: this outcome focuses on assessing reflections from both participants and gym staff on potential safety implications of using the 'Goodair Nosebuds'.
• Measurement Method: Qualitative insights gathered from both participants and gym staff using individual interviews or focus groups.
Individual interviews will be semi-structured, one-on-one face to face interviews with a member of the research team. If individual interviews are not feasible, focus groups will be conducted as an alternative. These focus groups will consist of 4-6 participants and will be facilitated by a trained member of the research team. The focus groups will encourage discussion among participants and/or gym staff about their views on the safety of the Goodair Nosebuds.
Timepoint [9] 428401 0
Immediately after the 8-week intervention period.
Secondary outcome [10] 428402 0
Personal Perspectives:
• Description: Capture of individual opinions, feelings, perceived benefits, and concerns related to the 'Goodair Nosebuds' intervention from both participants and gym staff.
• Measurement Method: Qualitative feedback through individual interviews or focus groups with both groups.
Individual interviews will be semi-structured, one-on-one face to face interviews with a member of the research team. If individual interviews are not feasible, focus groups will be conducted as an alternative. These focus groups will consist of 4-6 participants and will be facilitated by a trained member of the research team.
Timepoint [10] 428402 0
immediately after the 8-week intervention period.

Eligibility
Key inclusion criteria
The key inclusion criteria for this study are as follows:

For Study Group 1 - Older gym-goers:

Must be an adult aged 65 years or older.
Must be a current attendee of the Lilyfield Uniting Care gym.
Must have the ability to understand and speak English.
Must be a non-smoker.

For Study Group 2 - Staff:
Must be an exercise physiologist or other staff member working at the Lilyfield Uniting Care gym.
Must have the ability to understand and speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The key exclusion criteria for this study are as follows:

For Study Group 1 - Older gym-goers:

History of severe nose bleeding within the last 3 months.
Nasal blockage due to congestion or anatomical features.
Any reasons identified by a GP that would prevent participation (e.g. low blood pressure).
Allergic sensitivity to silicone or any other component of the device.
Inability to read and understand English.
Inability to follow instructions.
For Study Group 2 - Exercise Physiologist/Staff:

Exercise physiologists or staff members who have not been involved in the use of the device in the feasibility study.
Exercise physiologists or staff members who are unable to participate in the focus group/interview in English.

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For Study Group 1 - Residents, we will generate descriptive statistics for demographic and feasibility data using REDCap. Changes in scores for the Active Australia Survey, PSS, CASP-19, and PSQI will be examined using the Wilcoxon signed-rank test, comparing baseline and post-intervention measurements. Should post-intervention measurements be unavailable, we will employ an intention-to-treat analysis, carrying over baseline measurements. A p-value of less than 0.05 will be considered statistically significant.

For Study Group 2 - Gym Staff, we will generate descriptive reports of participants, including details such as age, gender, and job description.

Qualitative Analysis

For both Group 1 and Group 2, recordings from focus groups/interviews will be transcribed verbatim using Microsoft Dictate. The transcriptions will then be inductively coded using NVivo™ (V12 Pro). A thematic analysis will be conducted on the data derived from the focus groups/interviews to identify common content and themes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40385 0
2040 - Lilyfield

Funding & Sponsors
Funding source category [1] 313862 0
University
Name [1] 313862 0
Internal funding from University of Technology Sydney (School of Nursing and Midwifery)
Country [1] 313862 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
University of Technology Sydney, 15, Broadway, Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 317142 0
None
Name [1] 317142 0
Address [1] 317142 0
Country [1] 317142 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313009 0
University of Technology Sydney- Human Research Ethics Committee
Ethics committee address [1] 313009 0
Ethics committee country [1] 313009 0
Australia
Date submitted for ethics approval [1] 313009 0
17/06/2024
Approval date [1] 313009 0
Ethics approval number [1] 313009 0

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

Contacts
Principal investigator
Name 126670 0
Dr Priya Saravanakumar
Address 126670 0
Senior Lecturer, School of Nursing and Midwifery, Faculty of Health, University of Techology Sydney235 Jones St, Ultimo, NSW 2007.
Country 126670 0
Australia
Phone 126670 0
+61 2 95145845
Fax 126670 0
Email 126670 0
[email protected]
Contact person for public queries
Name 126671 0
Priya Saravanakumar
Address 126671 0
Senior Lecturer, School of Nursing and Midwifery, Faculty of Health, University of Techology Sydney235 Jones St, Ultimo, NSW 2007.
Country 126671 0
Australia
Phone 126671 0
+61 2 95145845
Fax 126671 0
Email 126671 0
[email protected]
Contact person for scientific queries
Name 126672 0
Priya Saravanakumar
Address 126672 0
Senior Lecturer, School of Nursing and Midwifery, Faculty of Health, University of Techology Sydney235 Jones St, Ultimo, NSW 2007.
Country 126672 0
Australia
Phone 126672 0
+61 2 95145845
Fax 126672 0
Email 126672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Specifically, the data that will be shared includes anonymized, aggregated and published results from the study.This will include the quantitative (feasibility, self-reported measures of physical activity, self-perceived stress, sleep quality and quality of life) and qualitative data (thematically analysed, narrative about the user experience and staff perceptions of the intervention).
When will data be available (start and end dates)?
The data will be available after the study results have been published in a peer reviewed publication.
We anticipate the data will be available from December 2024 and onwards, and we anticipate maintaining the study data for ongoing and future research purposes via UTS Stash, a secure data management system.
Available to whom?
The anonymised and aggregated data will be available upon request via UTS Stash, a secure data management system. Access will be granted on a case-by-case basis and will be contingent upon the approval of a proposal that aligns with ethical standards for the use of such data, including respect for participant confidentiality and the intent of the original informed consent. It will also require a data use agreement that stipulates how the data can be used, safeguards for data security, and a commitment to use the data only for the approved purpose.
Available for what types of analyses?
The anonymised individual participant data will be available for further analyses that align with the original purposes of the study. This could include, but is not limited to, secondary analyses to explore additional research questions related to the effects of the humming-assisted device on physical activity and wellbeing in older adults, or meta-analyses that combine the data from this study with other similar studies to provide a more comprehensive understanding of the intervention's effects. The specific types of analyses will be determined by the research questions outlined in the methodologically sound proposal provided by the requesting researcher. It is important to note that any proposed analyses must respect the intent of the original informed consent provided by the participants.
How or where can data be obtained?
Anonymised and aggregated data can be requested by emailing the primary investigator and the data can be accessed from UTS Stash, a secure data management system. The primary invesigator's contact address:[email protected]


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.