Obstructive Sleep ApneaNCT03124069

A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea

A study testing F&P Saturn in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 18 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: F&P Saturn
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2017to 30 Sep 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

AHI ≥ 5 from diagnostic PSG night
Aged 22 and over (FDA defined as adult)
Either prescribed APAP, CPAP or Bi-Level PAP for OSA
Existing nasal or nasal pillows mask users (preferable 70%:30% split)
Fluent in spoken and written English

Who cannot join

Inability to give informed consent
Patient intolerant to CPAP therapy
Anatomical or physiological conditions making PAP therapy inappropriate
Current diagnosis of respiratory disease or CO2 retention
Pregnant or think they may be pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Trials of Florida
South Miami, Florida, 33186

Other trials in United States

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 patients who currently use a nasal or nasal pillows mask will be recruited

This study will involve a baseline (Visit One) 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 for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.

The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

Conditions: Obstructive Sleep Apnea
Being tested: F&P Saturn
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.

F&P SaturnDevice
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.

Study groups in NCT03124069
Study group	Role	What they receive
F&P Saturn	Experimental	Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Receives: Device: F&P Saturn

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Comfort Compared to Their Usual Mask.
Comfort reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Measured: 14 ± 5 days In-Home
Number of Participants PAP Device Performance Reporting
Determined from data recorded from the PAP device to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Measured: 14 ± 5 days In-Home
Number of Participants Subjective Performance Rating of the Nasal Mask
Performance reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Measured: 14 ± 5 days In-Home
Number of Participants Subjective Reporting of Nasal Mask Usability
Usability reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Measured: During Visit Two - 20 minutes
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Ease of use reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Measured: 14 ± 5 days In-Home

Secondary outcomes (2)

Number of Participants Leak Compared to Usual Mask
Leak data recorded from PAP device to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Measured: 14 ± 5 days In-Home
Number of Participants With Correct Nasal Mask Size Determination
Sizing determined from a customized fitting tool to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Measured: 1 day-time appointment (1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201730 Sep 2017

First posted21 Apr 2017
Study start24 Apr 2017
Primary completion26 May 2017
Study completion30 Sep 2017

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.
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: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03124069
Sponsor's protocol ID: CIA-211
Status last verified: Jun 2021
First submitted: 11 Apr 2017
Last updated: 14 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Data will not be shared with any other researchers or parties.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT03124069
Acronym / sponsor ID: CIA-211
Conditions: Obstructive Sleep Apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
Study start: 24 Apr 2017 (actual)
Primary completion: 26 May 2017 (actual)
Study completion: 30 Sep 2017 (actual)
First posted: 21 Apr 2017 (actual)
Results: Posted 14 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 patients who currently use a nasal or nasal pillows mask will be recruited

Neither the investigators nor the participants 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
F&P Saturn	Experimental	Device: F&P SaturnParticipants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

AHI ≥ 5 from diagnostic PSG night
Aged 22 and over (FDA defined as adult)
Either prescribed APAP, CPAP or Bi-Level PAP for OSA
Existing nasal or nasal pillows mask users (preferable 70%:30% split)
Fluent in spoken and written English

Key exclusion criteria (5 listed)

Inability to give informed consent
Patient intolerant to CPAP therapy
Anatomical or physiological conditions making PAP therapy inappropriate
Current diagnosis of respiratory disease or 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
F&P SaturnParticipants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.	Device	F&P Saturn

Primary outcome

Number of Participants Reporting Comfort Compared to Their Usual Mask.
Time frame: 14 ± 5 days In-Home
Comfort reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants PAP Device Performance Reporting
Time frame: 14 ± 5 days In-Home
Determined from data recorded from the PAP device to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Performance Rating of the Nasal Mask
Time frame: 14 ± 5 days In-Home
Performance reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Reporting of Nasal Mask Usability
Time frame: During Visit Two - 20 minutes
Usability reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Time frame: 14 ± 5 days In-Home
Ease of use reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea

2 secondary outcomes

Number of Participants Leak Compared to Usual Mask
Time frame: 14 ± 5 days In-Home
Number of Participants With Correct Nasal Mask Size Determination
Time frame: 1 day-time appointment (1 hour)

Results and safety

Results posted to the registry on 14 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
F&P Nasal Mask	37	37

Primary outcome: Number of Participants Reporting Comfort Compared to Their Usual Mask.

Time frame: 14 ± 5 days In-Home. Count of participants. Unit: Participants

Measure	F&P Nasal n = 37
Much better	17
Better	4
Same	9
Worse	6
Much Worse	1

Primary outcome: Number of Participants PAP Device Performance Reporting

Time frame: 14 ± 5 days In-Home. Count of participants. Unit: Participants

Measure	F&P Nasal n = 37
Better than usual mask	9
Same as usual mask	13
Worse than usual mask	2
No data	13

Primary outcome: Number of Participants Subjective Performance Rating of the Nasal Mask

Time frame: 14 ± 5 days In-Home. Count of participants. Unit: Participants

Measure	F&P Nasal n = 37
Very good	23
Good	6
Acceptable	4
Poor	4
Very Poor	0

Primary outcome: Number of Participants Subjective Reporting of Nasal Mask Usability

Time frame: During Visit Two - 20 minutes. Count of participants. Unit: Participants

Measure	F&P Nasal n = 37
Very Easy	23
Easy	9
Acceptable	5
Difficult	0
Very Difficult	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
F&P Nasal Mask	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Data will not be shared with any other researchers or parties.

Related trials for Obstructive Sleep Apnea

Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality

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 F&P Saturn 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 5 inclusion and 5 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 14 Jul 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 14 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 Reporting Comfort Compared to Their Usual Mask. (time frame: 14 ± 5 days In-Home). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03124069.

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 14 Jul 2021.