Obstructive Sleep ApneaNCT02809859

CPAP In-home Assessment USA

A study testing Fisher & Paykel Healthcare CPAP Device in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 4 sites 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

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months. 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?: Fisher & Paykel Healthcare CPAP Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 4 sitesUnited States
Study dates: Jul 2016to Apr 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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 22 and over
Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Who cannot join

Contraindicated for PAP (CPAP or AutoCPAP) therapy
Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
Has obesity hypoventilation syndrome or congestive heart failure
Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
Has implanted electronic medical devices (e.g cardiac pacemakers)
Pregnant or think they may be pregnant
Not fluent in spoken and written English.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Ohio Sleep Medicine and Neurosciences Institute
Dublin, Ohio, 43017
Alabama Sleep Clinic
Huntsville, Alabama, 35801
Pulmonary Disease Specialists - Central Florida Sleep Centre
Kissimmee, Florida, 34741
Clayton Sleep Institute
St Louis, Missouri, 63143

Other trials in United States

About this study

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Read the detailed description

Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Conditions: Obstructive Sleep Apnea
Being tested: Fisher & Paykel Healthcare CPAP Device
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.

Fisher & Paykel Healthcare CPAP DeviceDevice
Fisher \& Paykel Healthcare CPAP Device

Study groups in NCT02809859
Study group	Role	What they receive
Investigational CPAP device	Experimental	Fisher \& Paykel Healthcare CPAP Device Receives: Device: Fisher & Paykel Healthcare CPAP Device

What is being measured

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

Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
Measured: 6 months
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
Measured: 6 months
Machine Reported Faults, Measured as Number of Patients With Machine Faults
Measured: 6 months
Participant Reported Faults, Measured as Number of Participant Complaints
Measured: 6 months

Secondary outcomes (1)

How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
Measured: 6 months

Timeline

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

Jul 2016Apr 2017

First posted22 Jun 2016 (estimated)
Study startJul 2016
Primary completionApr 2017
Study completionApr 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
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02809859
Sponsor's protocol ID: CIA176
Status last verified: Feb 2019
First submitted: 19 Jun 2016
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
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RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
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)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
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All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CPAP In-home Assessment USA
ClinicalTrials.gov ID: NCT02809859
Acronym / sponsor ID: CIA176
Conditions: Obstructive Sleep Apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
Study start: Jul 2016
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 22 Jun 2016 (estimated)
Results: Posted 5 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Investigational CPAP device	Experimental	Device: Fisher & Paykel Healthcare CPAP DeviceFisher \& Paykel Healthcare CPAP Device

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged 22 and over
Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Key exclusion criteria (7 listed)

Contraindicated for PAP (CPAP or AutoCPAP) therapy
Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
Has obesity hypoventilation syndrome or congestive heart failure
Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
Has implanted electronic medical devices (e.g cardiac pacemakers)

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
Fisher & Paykel Healthcare CPAP DeviceFisher \& Paykel Healthcare CPAP Device	Device	Investigational CPAP device

Primary outcome

Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
Time frame: 6 months
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
Time frame: 6 months
Machine Reported Faults, Measured as Number of Patients With Machine Faults
Time frame: 6 months
Participant Reported Faults, Measured as Number of Participant Complaints
Time frame: 6 months

1 secondary outcome

How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
Time frame: 6 months

Results and safety

Results posted to the registry on 5 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational CPAP Device	139	125

Primary outcome: Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.

Time frame: 6 months. Mean (Standard Deviation). Unit: events/hr

Measure	Investigational CPAP Device n = 139
Value	1.9 (2.9)

Primary outcome: Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults

Time frame: 6 months. Number. Unit: participants

Measure	Investigational CPAP Device n = 139
Value	0

Primary outcome: Machine Reported Faults, Measured as Number of Patients With Machine Faults

Time frame: 6 months. Number. Unit: participants

Measure	Investigational CPAP Device n = 139
Value	3

Primary outcome: Participant Reported Faults, Measured as Number of Participant Complaints

Time frame: 6 months. Number. Unit: complaints

Measure	Investigational CPAP Device n = 139
Value	9

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during the study period of each participant (i.e. 6 months). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational CPAP Device	2 of 139 (1.4%)	0 of 139 (0%)	1 of 139

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
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)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
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.

Matt Uhles principal investigator

Clayton Sleep Institute

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fisher & Paykel Healthcare CPAP Device in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 4 sites 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 3 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 5 Mar 2019). 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?

Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour. (time frame: 6 months). The study lists 4 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 NCT02809859.

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 5 Mar 2019.