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

ResMed

Status: Completed

Conditions: Breathing, Mouth

Treatments: Device: Therapy; Other: No device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04776122

eLB0409-316

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Control with no device

Active Comparator group

Description:

Breathing performed with no device

Treatment:

Other: No device

Therapy - device assisted breathing

Experimental group

Description:

Breathing performed with device

Treatment:

Device: Therapy