Sleep Disordered BreathingNCT02730273
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
A study testing Trial Nasal mask in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, 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
- 12 participants
- Where
- 1 siteNew Zealand
- Study dates
- Mar 2016to Apr 2016
- 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
- Adult (18+ years of age)
- Able to give consent
- Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
- Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
- Existing nasal or nasal pillow mask user
Who cannot join
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness.
- Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of CO2 retention
- Pregnant or may think they are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial.
- Being tested
- Trial Nasal mask
- Medical subject headings
- Sleep Apnea Syndromes, 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
Nasal mask for the treatment of obstructive sleep apnea (OSA)
| Study group | Role | What they receive |
|---|---|---|
| Trial Nasal Mask | Experimental | Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography. Receives: Device: Trial Nasal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective leak data (L/min)
Obtained from the participant's device
Measured: Up to 1 week in-home
Subjective measurement of leak
Subjective Questionnaire
Measured: Up to 1 week in-home
Comfort
Subjective Questionnaire
Measured: Up to 1 week in-home
Stability
Subjective Questionnaire
Measured: Up to 1 week in-home
Draft
Subjective Questionnaire
Measured: Up to 1 week in-home
Noise
Subjective Questionnaire
Measured: Up to 1 week in-home
Objective leak data (L/min)
Obtained from the overnight polysomnography
Measured: 1 night
Secondary outcomes (1)
Preference of the mask
Subjective Questionnaire
Measured: Up to 1 week in-home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kayan Gonda, BSc, Principal investigator, Sponsor Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730273
- Sponsor's protocol ID
- CIA-184
- Status last verified
- Jul 2017
- First submitted
- 13 Mar 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For product development purposes only. Data will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02730273
- Acronym / sponsor ID
- CIA-184
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Apr 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 performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial.
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 maskParticipants to use nasal mask in-home for a week and one night in lab overnight polysomnography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18+ years of age)
- Able to give consent
- Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
- Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
- Existing nasal or nasal pillow mask user
Key exclusion criteria (6 listed)
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness.
- Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- 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 maskNasal mask for the treatment of obstructive sleep apnea (OSA) | Device | Trial Nasal Mask |
Primary outcome
Objective leak data (L/min)
Time frame: Up to 1 week in-home
Obtained from the participant's device
Subjective measurement of leak
Time frame: Up to 1 week in-home
Subjective Questionnaire
Comfort
Time frame: Up to 1 week in-home
Subjective Questionnaire
Stability
Time frame: Up to 1 week in-home
Subjective Questionnaire
Draft
Time frame: Up to 1 week in-home
Subjective Questionnaire
Noise
Time frame: Up to 1 week in-home
Subjective Questionnaire
Objective leak data (L/min)
Time frame: 1 night
Obtained from the overnight polysomnography
1 secondary outcome
Preference of the mask
Time frame: Up to 1 week 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 17 Jul 2017.
- Individual participant dataSharing planned: No. For product development purposes only. Data will be deidentified.
Related trials for Sleep Disordered Breathing
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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.
Kayan Gonda, BSc principal investigator
Sponsor Employee
1 site 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 Sleep Disordered Breathing and 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 5 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 17 Jul 2017. 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?
Objective leak data (L/min) (time frame: Up to 1 week in-home). The study lists 7 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 17 Jul 2017.