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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04776122




Registration number
NCT04776122
Ethics application status
Date submitted
6/04/2020
Date registered
1/03/2021
Date last updated
1/03/2021

Titles & IDs
Public title
Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)
Scientific title
Breathing and CBT Platform Usability Take-home Study
Secondary ID [1] 0 0
eLB0409-316
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathing, Mouth 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Therapy
Other interventions - No device

Active Comparator: Control with no device - Breathing performed with no device

Experimental: Therapy - device assisted breathing - Breathing performed with device


Treatment: Devices: Therapy
Device-assisted breathing for relaxation

Other interventions: No device
Breathing platform without device
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ease of use
Timepoint [1] 0 0
8 days
Secondary outcome [1] 0 0
Compliance
Timepoint [1] 0 0
8 days

Eligibility
Key inclusion criteria
- Participants are willing to give written, informed consent

- Participants are healthy adults

- Participants are able to comprehend and speak English

- Participants are at least 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participants who are/may be pregnant or lactating

- Participant that have a pre-existing lung disease/ condition that would predispose
them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (<
2years) case of pneumonia or lung infection; lung injury)

- Participants who are unsuitable for the inclusion at the discretion of the
investigator

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)
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/07/2018
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ResMed Ltd - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will examine the usability of a breathing platform in the home environment. It will
be a randomized, open-label crossover study of 10 participants who will complete the CBT and
breathing components in their home, prior to sleeping. Usability will be measured by scores
assigned by participants. Qualitative feedback and compliance information will also be
collected.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04776122
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeff Armitstead
Address 0 0
ResMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04776122