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

Breathing and CBT Platform Usability Take-home Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04776122
Enrollment
10
Registered
2021-03-01
Start date
2018-06-01
Completion date
2018-07-30
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing, Mouth

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.

Interventions

DEVICETherapy

Device-assisted breathing for relaxation

Breathing platform without device

Sponsors

ResMed
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ease of use8 daysParticipants will complete a questionnaire rating how easy it was to use and sleep with the device providing assistance to their breathing patterns

Secondary

MeasureTime frameDescription
Compliance8 daysFrequency of use, as assessed by a short questionnaire asking how often patients used the device

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026