Obstructive Sleep ApneaNCT02541214
Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
A study testing Trial Nasal Mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
Trial summary
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask. This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure… 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?
- Trial Nasal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Sep 2015to Nov 2015
- 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
- Aged 18+
- Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
- Existing nasal or nasal pillows user
- Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
Who cannot join
- Inability to give informed consent
- Pregnant or think they may be pregnant
- Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
- Patients who are in a coma or decreased level of consciousness
- Current diagnosis of CO2 retention
- Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Waikato District Health Board
Hamilton, 3240
Hawke's Bay District Health Board
Hastings, 9014
About this study
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.
This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.
Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Trial Nasal 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.
Trial Nasal MaskDevice
| Study group | Role | What they receive |
|---|---|---|
| Trial Nasal Mask | Experimental | The participant will use the Saturn nasal mask for 2 weeks in home Receives: Device: Trial Nasal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
Measured: 2 weeks in home
Secondary outcomes (4)
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.
the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"
Measured: 2 weeks in home
Objective leak data through the Positive Airway Pressure therapy device
Evaluating the leak of the trial Nasal mask
Measured: 2 weeks in home
Treatment efficacy through the Positive Airway Pressure therapy device
Evaluating the number of apnea/hypopnea per hour
Measured: 2 weeks in home
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
the participant would either choose the trial Nasal mask or their usual mask as their primary mask
Measured: 2 weeks in home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionNov 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541214
- Sponsor's protocol ID
- CIA-171
- Status last verified
- Jul 2019
- First submitted
- 1 Sep 2015
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
- ClinicalTrials.gov ID
- NCT02541214
- Acronym / sponsor ID
- CIA-171
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Sep 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.
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.
This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.
Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial Nasal Mask | Experimental | Device: Trial Nasal MaskThe participant will use the Saturn nasal mask for 2 weeks in home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18+
- Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
- Existing nasal or nasal pillows user
- Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
Key exclusion criteria (6 listed)
- Inability to give informed consent
- Pregnant or think they may be pregnant
- Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
- Patients who are in a coma or decreased level of consciousness
- Current diagnosis of CO2 retention
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 |
|---|---|---|
| Trial Nasal Mask | Device | Trial Nasal Mask |
Primary outcome
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
Time frame: 2 weeks in home
4 secondary outcomes
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.
Time frame: 2 weeks in home
Objective leak data through the Positive Airway Pressure therapy device
Time frame: 2 weeks in home
Treatment efficacy through the Positive Airway Pressure therapy device
Time frame: 2 weeks in home
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
Time frame: 2 weeks 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 2 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trial Nasal Mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites 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 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire (time frame: 2 weeks 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 2 Aug 2019.