Sleep Apnea, ObstructiveNCT00697424
Comparison of Breathing Events Detected by the SleepStyle 200 Auto Continuous Positive Airway Pressure (CPAP) Device to Attended Polysomnography
A study testing SleepStyle 200 Auto Series CPAP Humidifier in people with Sleep Apnea, Obstructive, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- SleepStyle 200 Auto Series CPAP Humidifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 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
- Apnea Hypopnea Index (AHI) >15 from diagnostic night
- ≥18 years of age
Who cannot join
- Contraindicated for CPAP use
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Auckland Hospital, Adult Sleep & Ventilation Service, Auckland City Hospital
Auckland, 1010
About this study
Official title: Investigation of Methods to Detect Respiratory Irregularities in Obstructive Sleep Apnea (OSA)
Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health consequences include impaired cognitive functioning, quality of life, mood, and increased cardiovascular disease risk. Epidemiological studies have demonstrated that increased morbidity and mortality in a dose response manner with increasing severity of sleep disordered breathing.
The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which consists of pressurized air applied to the nose via a mask. Generally a single, optimal pressure is prescribed for a patient based on a full night or partial night study during which the pressure is adjusted by a technician until all sleep disordered breathing (SDB) events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal.
Read more
Due to low compliance it has become common for healthcare providers to follow up subject therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare providers can use this reported data to make appropriate treatment decisions. For this reason the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto adjusting CPAP which stores comprehensive compliance data. The aim of this study is to compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG in detecting sleep disordered breathing.
Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of sleep disordered breathing.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- SleepStyle 200 Auto 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 200 Auto Series CPAP HumidifierDevice
The device will record on internal software perceived sleep disordered breathing events. Events will also be scored manually on the polysomnography (PSG. Results will then be compared.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects will be placed on continuous positive airway pressure (CPAP) therapy during a full night sleep study or polysomnography (PSG). The subjects will spend 2 hours on sub-therapeutic CPAP 4 cmH2O of pressure and the remainder on there therapeutic pressure. Values reported on the device will be compared to scored values from manual scoring of the sleep study. Receives: Device: SleepStyle 200 Auto Series CPAP Humidifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
Measured: At the end of the sleep study.
Secondary outcomes (1)
Respiratory Disturbance Index (RDI)
Measured: At the end of the sleep study (PSG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startMay 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 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jessica R Hayward, Msc, Principal investigator, Fisher & Paykel Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697424
- Sponsor's protocol ID
- FPHHC254a
- Other IDs
- AKY/03/07/166
- Status last verified
- Dec 2008
- First submitted
- 11 Jun 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
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
- Investigation of Methods to Detect Respiratory Irregularities in Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT00697424
- Acronym / sponsor ID
- FPHHC254a
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Jun 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.
Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health consequences include impaired cognitive functioning, quality of life, mood, and increased cardiovascular disease risk. Epidemiological studies have demonstrated that increased morbidity and mortality in a dose response manner with increasing severity of sleep disordered breathing.
The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which consists of pressurized air applied to the nose via a mask. Generally a single, optimal pressure is prescribed for a patient based on a full night or partial night study during which the pressure is adjusted by a technician until all sleep disordered breathing (SDB) events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal.
Due to low compliance it has become common for healthcare providers to follow up subject therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare providers can use this reported data to make appropriate treatment decisions. For this reason the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto adjusting CPAP which stores comprehensive compliance data. The aim of this study is to compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG in detecting sleep disordered breathing.
Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of sleep disordered breathing.
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 200 Auto Series CPAP HumidifierAll subjects will be placed on continuous positive airway pressure (CPAP) therapy during a full night sleep study or polysomnography (PSG). The subjects will spend 2 hours on sub-therapeutic CPAP 4 cmH2O of pressure and the remainder on there therapeutic pressure. Values reported on the device will be compared to scored values from manual scoring of the sleep study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apnea Hypopnea Index (AHI) >15 from diagnostic night
- ≥18 years of age
Key exclusion criteria (1 listed)
- Contraindicated for CPAP use
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 200 Auto Series CPAP HumidifierThe device will record on internal software perceived sleep disordered breathing events. Events will also be scored manually on the polysomnography (PSG. Results will then be compared. | Device | 1 |
Primary outcome
Apnea Hypopnea Index
Time frame: At the end of the sleep study.
1 secondary outcome
Respiratory Disturbance Index (RDI)
Time frame: At the end of the sleep study (PSG)
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.
- Sponsors web siteLink provided by the sponsor.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Jessica R Hayward, Msc principal investigator
Fisher & Paykel Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepStyle 200 Auto Series CPAP Humidifier in people with Sleep Apnea, Obstructive, 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 1 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 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 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 (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.