Obstructive Sleep Apnea (OSA)NCT00739011
Validation of HC250 and HC240 Series.
A study testing SleepStyle 254/244 CPAP series CPAP humidifier in people with Obstructive Sleep Apnea (OSA), run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
Trial summary
This study is designed to determine the effectiveness of two different CPAP devices. One a standard CPAP which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- SleepStyle 254/244 CPAP series CPAP humidifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Aug 2008to Nov 2008
- 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
None listed.
Who cannot join
- Significant Central Apnea
- CHF
- Co-existing obesity related hypoventilation
- Inability to give informed consent
- Patient intolerance to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate.
- Less than 3 hours in the titration period
- Under Land Transport New Zealand (LTNZ) investigation
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland Hospital Sleep laboratory
Auckland
Auckland Physiology Sleep Lab
Auckland
About this study
Official title: Validation of Customer Requirements for the HC244/HC254
This study is designed to determine the effectiveness of two different CPAP devices. One a standard CPAP which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables.
Read the detailed description
All patients with suspected obstructive sleep apnea presenting at the Auckland Hospital Sleep Laboratory and referred for either a split-night or full night diagnostic study, will be offered participation in the study and will be recruited. From these patients, a total of 20 patients that are diagnosed with clinical obstructive sleep apnea syndrome, based on diagnostic polysomnography, will undergo titration with the HC254 Auto CPAP. An additional 20 patients will undergo titration with the HC244 CPAP.
The sleep physiologist evaluating the patient clinically will approach patients for participation in this study during their sleep laboratory visit. Consenting patients will undergo either an initial full night diagnostic polysomnography or a split night study as determined by the physician based on clinical requirements. Patients diagnosed with obstructive sleep apnea (AHI > 15/hr) during this diagnostic component will then undergo one of the following:
- Treatment with the HC254 Auto CPAP during the second half of the study.
- Treatment with the HC244 CPAP during the second half of the study.
The sleep physiologist will then determine final CPAP prescriptions for all patients based on the patient's response to CPAP therapy.
5 subjects who have completed the HC254 arm of the study will be brought back to the sleep lab for an additional PSG or partial PSG while on CPAP pressure set to 90th percentile pressure determined on the diagnostic night.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- SleepStyle 254/244 CPAP series CPAP humidifier
- 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.
SleepStyle 254/244 CPAP series CPAP humidifierDevice
Therapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: SleepStyle 254/244 CPAP series CPAP humidifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
Measured: At the end of the sleep study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jessica Hayward, MSc, Principal investigator, Fisher and Paykel Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739011
- Sponsor's protocol ID
- FPHC240/250Val
- Status last verified
- Dec 2008
- First submitted
- 19 Aug 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Customer Requirements for the HC244/HC254
- ClinicalTrials.gov ID
- NCT00739011
- Acronym / sponsor ID
- FPHC240/250Val
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Aug 2008 (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 is designed to determine the effectiveness of two different CPAP devices. One a standard CPAP which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables.
Detailed description
All patients with suspected obstructive sleep apnea presenting at the Auckland Hospital Sleep Laboratory and referred for either a split-night or full night diagnostic study, will be offered participation in the study and will be recruited. From these patients, a total of 20 patients that are diagnosed with clinical obstructive sleep apnea syndrome, based on diagnostic polysomnography, will undergo titration with the HC254 Auto CPAP. An additional 20 patients will undergo titration with the HC244 CPAP.
The sleep physiologist evaluating the patient clinically will approach patients for participation in this study during their sleep laboratory visit. Consenting patients will undergo either an initial full night diagnostic polysomnography or a split night study as determined by the physician based on clinical requirements. Patients diagnosed with obstructive sleep apnea (AHI > 15/hr) during this diagnostic component will then undergo one of the following:
- Treatment with the HC254 Auto CPAP during the second half of the study.
- Treatment with the HC244 CPAP during the second half of the study.
The sleep physiologist will then determine final CPAP prescriptions for all patients based on the patient's response to CPAP therapy.
5 subjects who have completed the HC254 arm of the study will be brought back to the sleep lab for an additional PSG or partial PSG while on CPAP pressure set to 90th percentile pressure determined on the diagnostic night.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: SleepStyle 254/244 CPAP series CPAP humidifier |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Significant Central Apnea
- CHF
- Co-existing obesity related hypoventilation
- Inability to give informed consent
- Patient intolerance to CPAP
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 |
|---|---|---|
| SleepStyle 254/244 CPAP series CPAP humidifierTherapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20 | Device | 1 |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: At the end of the sleep study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
Related trials for Obstructive Sleep Apnea (OSA)
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.
Jessica Hayward, MSc principal investigator
Fisher and Paykel Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepStyle 254/244 CPAP series CPAP humidifier in people with Obstructive Sleep Apnea (OSA), run by Fisher and Paykel Healthcare at 2 sites 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 0 inclusion and 8 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 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: At the end of the sleep study). 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 9 Dec 2008.