Breathing, MouthNCT04776122
Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)
A study testing Therapy and No device in people with Breathing, Mouth, run by ResMed at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breathing, Mouth
- What is being tested?
- Therapy and No device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breathing, Mouth
- Being tested
- Therapy, No device
- Medical subject headings
- Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyDevice
Device-assisted breathing for relaxation
No deviceOther
Breathing platform without device
| Study group | Role | What they receive |
|---|---|---|
| Control with no device | Active comparator | Breathing performed with no device Receives: Other: No device |
| Therapy - device assisted breathing | Experimental | Breathing performed with device Receives: Device: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 days
Secondary outcomes (1)
Compliance
Frequency of use, as assessed by a short questionnaire asking how often patients used the device
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jun 2018
- Primary completion30 Jun 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing, MouthStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Armitstead, Principal investigator, ResMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776122
- Sponsor's protocol ID
- eLB0409-316
- Status last verified
- Feb 2021
- First submitted
- 6 Apr 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing and CBT Platform Usability Take-home Study
- ClinicalTrials.gov ID
- NCT04776122
- Acronym / sponsor ID
- eLB0409-316
- Conditions
- Breathing, Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control with no device | Active comparator | Other: No deviceBreathing performed with no device |
| Therapy - device assisted breathing | Experimental | Device: TherapyBreathing performed with device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TherapyDevice-assisted breathing for relaxation | Device | Therapy - device assisted breathing |
| No deviceBreathing platform without device | Other | Control with no device |
Primary outcome
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
1 secondary outcome
Compliance
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Armitstead principal investigator
ResMed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy and No device in people with Breathing, Mouth, run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.