Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)

Not Applicable

Completed

• Conditions: Breathing, Mouth
• Interventions: Device: Therapy; Other: No device

• Registration Number: NCT04776122
• Lead Sponsor: ResMed

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30
• Study First Submitted: 2020-04-06
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Therapy - device assisted breathing	Therapy	Breathing performed with device
Control with no device	No device	Breathing performed with no device

Primary Outcome Measures

Name	Time	Method
Ease of use	8 days	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

Name	Time	Method
Compliance	8 days	Frequency of use, as assessed by a short questionnaire asking how often patients used the device

Trial Locations

Locations (1)

ResMed Ltd; 🇦🇺 Sydney, Australia