HealthyNCT02473068
Non Invasive Ventilation Comfort Study
A study testing CPAP in people with Healthy, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNew Zealand
- Study dates
- 19 Jun 2015to 4 Jun 2019
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any employee of FPH willing to take part in the study following review of the Participant Information Sheet and who has provided affirmative answers to the questions / statements included on the Consent Form
Who cannot join
- Any employee of FPH not willing to take part in the study following review of the Participant Information Sheet.
- Any employee of FPH who has not provided affirmative answers to the questions / statements included on the Consent Form
Trial locations and contacts
1 site in 1 country.
About this study
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures.
Read the detailed description
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures. Healthy volunteers will be given two different levels humidity and temperature and asked about preference.
- Conditions
- Healthy
- Being tested
- CPAP
- Keywords
- CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 31°C. Receives: Device: CPAP |
| Group 2 | Experimental | In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 27°C. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Comfort Questionnaire
Participant answers questions to indicate comfort
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start19 Jun 2015
- Primary completion1 Jul 2016
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoff Bold, PhD, Principal investigator, Fisher & Paykel Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473068
- Sponsor's protocol ID
- CIA-170
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Ventilation Comfort Study
- ClinicalTrials.gov ID
- NCT02473068
- Acronym / sponsor ID
- CIA-170
- Conditions
- Healthy
- Keywords
- CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 16 Jun 2015 (estimated)
- 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.
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures.
Detailed description
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures. Healthy volunteers will be given two different levels humidity and temperature and asked about preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: CPAPIn random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 31°C. |
| Group 2 | Experimental | Device: CPAPIn random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 27°C. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any employee of FPH willing to take part in the study following review of the Participant Information Sheet and who has provided affirmative answers to the questions / statements included on the Consent Form
Key exclusion criteria (2 listed)
- Any employee of FPH not willing to take part in the study following review of the Participant Information Sheet.
- Any employee of FPH who has not provided affirmative answers to the questions / statements included on the Consent Form
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 |
|---|---|---|
| CPAP | Device | Group 1, Group 2 |
Primary outcome
Participant Comfort Questionnaire
Time frame: 30 Minutes
Participant answers questions to indicate comfort
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 5 Jul 2019.
- 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.
Geoff Bold, PhD principal investigator
Fisher & Paykel Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Healthy, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
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 1 inclusion and 2 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 5 Jul 2019. 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 New Zealand. 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?
Participant Comfort Questionnaire (time frame: 30 Minutes). 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 5 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.