Obstructive Sleep ApneaNCT02297789
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
A study testing Investigative Full Face Mask with Headgear in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Investigative Full Face Mask with Headgear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 2014to Dec 2014
- 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
- AHI ≥ 5 from the diagnostic night
- ≥ 18 years of age
- Either prescribed APAP or CPAP or Bi level for OSA
- Existing full face users
Who cannot join
- Inability to give informed consent
- Participant intolerance to PAP
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or think they may be pregnant
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Fisher & Paykel Healthcare Ltd.
Auckland, East Tamaki, 1010
About this study
Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.
The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Investigative Full Face Mask with Headgear
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigative Full Face Mask with HeadgearDevice
| Study group | Role | What they receive |
|---|---|---|
| Headgear 1 | Experimental | Full Face Mask with Headgear 1 Receives: Device: Investigative Full Face Mask with Headgear |
| Headgear 2 | Experimental | Full Face Mask with Headgear 2 Receives: Device: Investigative Full Face Mask with Headgear |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mask is comfortable and is effective for the participant during in-home use
Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.
Measured: 1 week for each mask prototype in-home
Secondary outcomes (1)
Acceptability of the Full Face mask prototypes
Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log
Measured: 1 week for each mask prototype in-home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhavi Ogra, BSc, Principal investigator, Fisher & Paykel Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297789
- Sponsor's protocol ID
- CIA-152
- Status last verified
- Jul 2015
- First submitted
- 19 Nov 2014
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02297789
- Acronym / sponsor ID
- CIA-152
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Nov 2014 (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.
Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.
The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headgear 1 | Experimental | Device: Investigative Full Face Mask with HeadgearFull Face Mask with Headgear 1 |
| Headgear 2 | Experimental | Device: Investigative Full Face Mask with HeadgearFull Face Mask with Headgear 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AHI ≥ 5 from the diagnostic night
- ≥ 18 years of age
- Either prescribed APAP or CPAP or Bi level for OSA
- Existing full face users
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Participant intolerance to PAP
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or think they may be pregnant
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 |
|---|---|---|
| Investigative Full Face Mask with Headgear | Device | Headgear 1, Headgear 2 |
Primary outcome
The mask is comfortable and is effective for the participant during in-home use
Time frame: 1 week for each mask prototype in-home
Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.
1 secondary outcome
Acceptability of the Full Face mask prototypes
Time frame: 1 week for each mask prototype in-home
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 24 Jul 2015.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Bhavi Ogra, BSc 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 Investigative Full Face Mask with Headgear in people with Obstructive Sleep Apnea, 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 4 inclusion and 5 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 24 Jul 2015. 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?
The mask is comfortable and is effective for the participant during in-home use (time frame: 1 week for each mask prototype in-home). 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 24 Jul 2015.