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OpenTrials
Completed

NCT Number: NCT04776122

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

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.

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Key information

Conditions

Breathing, Mouth Mouth Breathing Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ResMed Ltd

Sydney, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapy

Device

Device-assisted breathing for relaxation

No device

Other

Breathing platform without device

Primary outcomes

  1. Ease of use

    Time frame: 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 outcomes

  1. Compliance

    Time frame: 8 days

    Frequency of use, as assessed by a short questionnaire asking how often patients used the device

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Breathing and CBT Platform Usability Take-home Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2021
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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