Obstructive Sleep ApneaNCT02942446
Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask
A study testing Investigative Headgear with CPAP mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Investigative Headgear with CPAP mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- Oct 2016to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI≥5 from the diagnostic night
- ≥18 years of age
- Prescribed CPAP or Bi-level therapy for OSA
- Existing F\&P Pilairo Q, Eson, Simplus mask users
Who cannot join
- Inability to give informed consent
- Patient intolerant to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
- History of respiratory disease or carbon dioxide (CO2) retention
- Pregnant or think they may be pregnant
- Investigated by Land Transport Safety Authority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigative Headgear With Nasal Pillows CPAP Mask
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.
Read the detailed description
20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Investigative Headgear with CPAP mask
- 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 Headgear with CPAP maskDevice
Investigative Headgear with CPAP mask
| Study group | Role | What they receive |
|---|---|---|
| Headgear | Experimental | Investigative Headgear with CPAP mask Receives: Device: Investigative Headgear with CPAP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the headgear using a Questionnaire
Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Measured: Monthly over a period of 6 months
Durability of the headgear by testing
Assessment of headgear properties on a monthly basis, and changes to the headgear
Measured: Monthly over a period of 6 months
Secondary outcomes (2)
Performance in regards to leak of the headgear
Objective Leak Data (L/min) from the device download
Measured: Monthly over a period of 6 months
Performance in regards to comfort of the headgear
Custom Questionnaire
Measured: Monthly over a period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionDec 2017
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Gunson, BSc, Principal investigator, Clinical Research Associate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942446
- Sponsor's protocol ID
- CIA 150
- Status last verified
- Mar 2019
- First submitted
- 11 Oct 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigative Headgear With Nasal Pillows CPAP Mask
- ClinicalTrials.gov ID
- NCT02942446
- Acronym / sponsor ID
- CIA 150
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Oct 2016 (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.
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.
Detailed description
20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Headgear | Experimental | Device: Investigative Headgear with CPAP maskInvestigative Headgear with CPAP mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AHI≥5 from the diagnostic night
- ≥18 years of age
- Prescribed CPAP or Bi-level therapy for OSA
- Existing F\&P Pilairo Q, Eson, Simplus mask users
Key exclusion criteria (6 listed)
- Inability to give informed consent
- Patient intolerant to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
- History of respiratory disease or carbon dioxide (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 Headgear with CPAP maskInvestigative Headgear with CPAP mask | Device | Headgear |
Primary outcome
Reliability of the headgear using a Questionnaire
Time frame: Monthly over a period of 6 months
Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Durability of the headgear by testing
Time frame: Monthly over a period of 6 months
Assessment of headgear properties on a monthly basis, and changes to the headgear
2 secondary outcomes
Performance in regards to leak of the headgear
Time frame: Monthly over a period of 6 months
Performance in regards to comfort of the headgear
Time frame: Monthly over a period of 6 months
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 21 Mar 2019.
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.
Sarah Gunson, BSc principal investigator
Clinical Research Associate
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 Headgear with CPAP mask 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 6 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 21 Mar 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?
Reliability of the headgear using a Questionnaire (time frame: Monthly over a period of 6 months). The study lists 2 primary outcomes in all. 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 21 Mar 2019.