Sleep Apnea, ObstructiveNCT02368639
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
A study testing Fisher & Paykel Healthcare PAP Device in people with Sleep Apnea, Obstructive and Obesity Hypoventilation Syndrome, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography. Positive airway pressures are typically applied to many patients with hypoventilation, in this study these pressures will be titrated by a qualified sleep… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome
- What is being tested?
- Fisher & Paykel Healthcare PAP Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jan 2015to Mar 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
- Aged 18+
- Patients diagnosed with obesity hypoventilation syndrome (OHS) and/or obstructive sleep apnea (OSA) by a practicing sleep or respiratory physician, requiring positive airway pressure (PAP) therapy
Who cannot join
- Recent cardiac or respiratory arrest
- Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
- Coma, decreased level of consciousness or agitation
- Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
- Cerebrospinal fluid leak, abnormalities of the cribiform plate or prior history of head trauma.
Trial locations and contacts
1 site in 1 country.
About this study
This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography. Positive airway pressures are typically applied to many patients with hypoventilation, in this study these pressures will be titrated by a qualified sleep technician. During the night these pressures will be altered to optimise comfort.
- Being tested
- Fisher & Paykel Healthcare PAP Device
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisher & Paykel Healthcare PAP DeviceDevice
The device is a modified version of the Fisher \& Paykel Icon continuous positive airway pressure (CPAP) device, which is a fully released product in New Zealand.
| Study group | Role | What they receive |
|---|---|---|
| Positive airway pressure (PAP) device | Experimental | Fisher \& Paykel Healthcare PAP Device. Participants will sleep overnight using themodified positive airway pressure device. Their pressures will be titrated by a qualified sleep technician, they will then be optimised during the night. Receives: Device: Fisher & Paykel Healthcare PAP Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index (AHI)
The number of apnea and hypopneas will be measured
Measured: 8 hours
Peripheral blood oxygen level (SpO2)
Peripheral blood oxygen level will be measured
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: The study was terminated due to recruitment slower than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- 14 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
- NCT02368639
- Sponsor's protocol ID
- CIA-156
- Status last verified
- Aug 2017
- First submitted
- 8 Feb 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT02368639
- Acronym / sponsor ID
- CIA-156
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to recruitment slower than anticipated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Feb 2015 (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 study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography. Positive airway pressures are typically applied to many patients with hypoventilation, in this study these pressures will be titrated by a qualified sleep technician. During the night these pressures will be altered to optimise comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive airway pressure (PAP) device | Experimental | Device: Fisher & Paykel Healthcare PAP DeviceFisher \& Paykel Healthcare PAP Device. Participants will sleep overnight using themodified positive airway pressure device. Their pressures will be titrated by a qualified sleep technician, they will then be optimised during the night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18+
- Patients diagnosed with obesity hypoventilation syndrome (OHS) and/or obstructive sleep apnea (OSA) by a practicing sleep or respiratory physician, requiring positive airway pressure (PAP) therapy
Key exclusion criteria (5 listed)
- Recent cardiac or respiratory arrest
- Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
- Coma, decreased level of consciousness or agitation
- Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
- Cerebrospinal fluid leak, abnormalities of the cribiform plate or prior history of head trauma.
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 PAP DeviceThe device is a modified version of the Fisher \& Paykel Icon continuous positive airway pressure (CPAP) device, which is a fully released product in New Zealand. | Device | Positive airway pressure (PAP) device |
Primary outcome
Apnea hypopnea index (AHI)
Time frame: 8 hours
The number of apnea and hypopneas will be measured
Peripheral blood oxygen level (SpO2)
Time frame: 8 hours
Peripheral blood oxygen level will be measured
Results and safety
The study was stopped early (reason given: The study was terminated due to recruitment slower than anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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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 Fisher & Paykel Healthcare PAP Device in people with Sleep Apnea, Obstructive and Obesity Hypoventilation Syndrome, 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 2 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: stopped early, as of the sponsor's last update on 11 Aug 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 was stopped early (reason given: The study was terminated due to recruitment slower than anticipated). Results are not available in the source record.
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) (time frame: 8 hours). The study lists 2 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 11 Aug 2017.