Obstructive Sleep ApneaNCT04011826
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
A study testing Device: Trial nasal mask (F&P) in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Device: Trial nasal mask (F&P)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OSA by Physician
- ≥ 22 years of age
- ≥ 66 lbs
- Prescribed PAP or BPAP therapy for OSA
- Existing nasal, sub-nasal and pillows mask users
- Fluent in written and spoken English
Who cannot join
- Inability to give informed consent
- Pregnant or think they may be pregnant
- PAP Intolerant
- Anatomical or Physiological Conditions that make PAP inappropriate
- IPAP pressure of ≤25cmH20.
- PAP/BPAP therapy device without data recording capabilities
- Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Trial locations and contacts
1 site in 1 country.
About this study
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Read the detailed description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited.
The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Device: Trial nasal mask (F&P)
- 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.
Device: Trial nasal mask (F&P)Device
Also called New nasal mask
This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental trial nasal mask | Experimental | Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3. Receives: Device: Device: Trial nasal mask (F&P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Objective Trial Mask Performance
Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device.
Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F\&P nasal mask.
Measured: 14 ± 3 days in home
Secondary outcomes (3)
Number of Participants Trial Mask Overall Simplicity of Use
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging). Results below represent percentage of respondents for each value.
Measured: 14 ± 3 days in home
Number of Participants Subjective Trial Mask Comfort
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable). Participants reported their subject views on mask comfort. Responses to each likert scale option are presented below as percentages.
Measured: 14 ± 3 days in home
Number of Participants Overall Trial Mask Satisfaction
Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F\&P Nasal mask compared to participants' usual mask ).
Measured: 14 ± 3 days in home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start5 Aug 2019
- Primary completion30 Apr 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- After a period of baseline, all enrolled participants will be put on the same trial mask.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Muehlbach, Principal investigator, Clinical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011826
- Sponsor's protocol ID
- CIA-262
- Status last verified
- Nov 2021
- First submitted
- 2 Jul 2019
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with any other researchers or organizations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04011826
- Acronym / sponsor ID
- CIA-262
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Posted 6 Jul 2021
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 comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited.
The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After a period of baseline, all enrolled participants will be put on the same trial mask.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental trial nasal mask | Experimental | Device: Device: Trial nasal mask (F&P)Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of OSA by Physician
- ≥ 22 years of age
- ≥ 66 lbs
- Prescribed PAP or BPAP therapy for OSA
- Existing nasal, sub-nasal and pillows mask users
Key exclusion criteria (7 listed)
- Inability to give informed consent
- Pregnant or think they may be pregnant
- PAP Intolerant
- Anatomical or Physiological Conditions that make PAP inappropriate
- IPAP pressure of ≤25cmH20.
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 |
|---|---|---|
| Device: Trial nasal mask (F&P)Also: New nasal maskThis trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3. | Device | Experimental: Experimental trial nasal mask |
Primary outcome
Number of Participants Objective Trial Mask Performance
Time frame: 14 ± 3 days in home
Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device. Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F\&P nasal mask.
3 secondary outcomes
Number of Participants Trial Mask Overall Simplicity of Use
Time frame: 14 ± 3 days in home
Number of Participants Subjective Trial Mask Comfort
Time frame: 14 ± 3 days in home
Number of Participants Overall Trial Mask Satisfaction
Time frame: 14 ± 3 days in home
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared with any other researchers or organizations.
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.
Mark Muehlbach principal investigator
Clinical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Trial nasal mask (F&P) in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
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 6 inclusion and 7 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 1 Dec 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Objective Trial Mask Performance (time frame: 14 ± 3 days 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 1 Dec 2021.