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

Breathing, Mouth Clinical Trial

Official title:

Breathing and CBT Platform Usability Take-home Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776122
• Other study ID #: eLB0409-316
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breathing, Mouth
• Mouth Breathing
• Respiratory Aspiration

Intervention

Device:
• Therapy
Device-assisted breathing for relaxation

Other:
• No device
Breathing platform without device

Locations

Country	Name	City	State
Australia	ResMed Ltd	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 days
Secondary	Compliance	Frequency of use, as assessed by a short questionnaire asking how often patients used the device	8 days