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

Breathing and CBT Platform Usability Take-home Study

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.

Study Overview

• Status: Completed
• Conditions: Breathing, Mouth
• Intervention / Treatment: Other: No device; Device: Therapy

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • ResMed Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control with no device; Breathing performed with no device	Other: No device; Breathing platform without device
Experimental: Therapy - device assisted breathing; Breathing performed with device	Device: Therapy; Device-assisted breathing for relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Frequency of use, as assessed by a short questionnaire asking how often patients used the device	8 days

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Jeff Armitstead, ResMed

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Mouth Breathing
• Other Study ID Numbers: eLB0409-316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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