Back to resultsUsability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)
Primary Purpose
Breathing, Mouth
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Therapy
No device
Sponsored by
About this trial
This is an interventional treatment trial for Breathing, Mouth
Eligibility Criteria
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
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
Sites / Locations
- ResMed Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control with no device
Therapy - device assisted breathing
Arm Description
Breathing performed with no device
Breathing performed with device
Outcomes
Primary Outcome Measures
Ease of use
Participants will complete a questionnaire rating how easy it was to use and sleep with the device providing assistance to their breathing patterns
Secondary Outcome Measures
Compliance
Frequency of use, as assessed by a short questionnaire asking how often patients used the device
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04776122
Brief Title
Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)
Official Title
Breathing and CBT Platform Usability Take-home Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing, Mouth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control with no device
Arm Type
Active Comparator
Arm Description
Breathing performed with no device
Arm Title
Therapy - device assisted breathing
Arm Type
Experimental
Arm Description
Breathing performed with device
Intervention Type
Device
Intervention Name(s)
Therapy
Intervention Description
Device-assisted breathing for relaxation
Intervention Type
Other
Intervention Name(s)
No device
Intervention Description
Breathing platform without device
Primary Outcome Measure Information:
Title
Ease of use
Description
Participants will complete a questionnaire rating how easy it was to use and sleep with the device providing assistance to their breathing patterns
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Compliance
Description
Frequency of use, as assessed by a short questionnaire asking how often patients used the device
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Armitstead
Organizational Affiliation
ResMed
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed Ltd
City
Sydney
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)
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