Obstructive Sleep ApneaNCT04063436
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
A study testing New nasal pillows mask with PAP therapy in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a 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?
- New nasal pillows mask with PAP therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 11 Oct 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are ≥22 years of age
- Weigh ≥66 lbs
- Have been formally diagnosed with OSA by a physician
- Have an AHI ≥5 on a diagnostic night
- Have been prescribed PAP therapy to treat OSA by a physician
- Are an existing nasal pillows mask user
Show all 10Show fewer
- Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
- Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
- Are fluent in spoken and written English
- Possess the capacity to provide informed consent
Who cannot join
- Are intolerant to PAP therapy
- Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- Are currently diagnosed with respiratory disease or CO2 retention
- Are pregnant or think they may be pregnant
- Have an IPAP pressure of >25 cmH2O
- Persons who use a PAP therapy machine for the delivery of medicines, except O2
- Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- New nasal pillows mask with PAP therapy
- 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.
New nasal pillows mask with PAP therapyDevice
Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy. Receives: Device: New nasal pillows mask with PAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of new nasal pillows mask
The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.
Measured: 14±5 days
Secondary outcomes (2)
Comfort of new nasal pillows mask
The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.
Measured: 14±5 days
Usability of new nasal pillows mask
The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.
Measured: 14±5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start23 Sep 2019 (estimated)
- Primary completion11 Oct 2019 (estimated)
- Study completion11 Oct 2019 (estimated)
Why it stopped: Clinical trial was cancelled
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
- Model description
- After the baseline period, all participants will be trialed on the same new nasal pillows mask.
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04063436
- Sponsor's protocol ID
- CIA-264
- Status last verified
- Mar 2020
- First submitted
- 13 Aug 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04063436
- Acronym / sponsor ID
- CIA-264
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical trial was cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (estimated)
- Primary completion
- 11 Oct 2019 (estimated)
- Study completion
- 11 Oct 2019 (estimated)
- First posted
- 21 Aug 2019 (actual)
- 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 clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After the baseline period, all participants will be trialed on the same new nasal pillows mask.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: New nasal pillows mask with PAP therapyParticipants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Are ≥22 years of age
- Weigh ≥66 lbs
- Have been formally diagnosed with OSA by a physician
- Have an AHI ≥5 on a diagnostic night
- Have been prescribed PAP therapy to treat OSA by a physician
Key exclusion criteria (7 listed)
- Are intolerant to PAP therapy
- Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- Are currently diagnosed with respiratory disease or CO2 retention
- Are pregnant or think they may be pregnant
- Have an IPAP pressure of >25 cmH2O
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 |
|---|---|---|
| New nasal pillows mask with PAP therapyParticipants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy. | Device | Experimental |
Primary outcome
Performance of new nasal pillows mask
Time frame: 14±5 days
The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.
2 secondary outcomes
Comfort of new nasal pillows mask
Time frame: 14±5 days
Usability of new nasal pillows mask
Time frame: 14±5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New nasal pillows mask with PAP therapy 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 10 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: withdrawn, as of the sponsor's last update on 23 Mar 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Performance of new nasal pillows mask (time frame: 14±5 days). 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 23 Mar 2020.