Sleep Apnea, ObstructiveNCT00750165
Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
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 United States.
Trial summary
Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2008
- 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 >15 on the diagnostic portion of the study
- >18 years of age
Who cannot join
- Significant Central Apnea
- Congestive Heart Failure
- Inability to give informed consent
- Patient intolerance to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Sleep Disorders Center
New York, New York, 10016
About this study
Official title: Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.
Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- SleepStyle 200 Auto Series CPAP Humidifier
- Keywords
- Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
- 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
Also called HC254
The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
| Study group | Role | What they receive |
|---|---|---|
| Titration Night | Experimental | Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device 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 (AHI)
The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.
Measured: 1 night
Secondary outcomes (3)
Percent of Time With Less Than 90% Oxygen Saturation
Oxygen saturation is a measurement of the amount of oxygen present in the blood. An oxygen saturation of less than 90% is considered low, resulting in hypoxemia. Normal blood oxygen level is considered between 95-100%.
Measured: 1 Night
Respiratory Disturbance Index (RDI)
Similar to AHI, the RDI is a calculation of the total number of respiratory disturbances in sleep. The calculation includes apneas and hypopneas, but also includes respiratory effort related arousals.
Measured: 1 Night
Arousal Index (AI)
The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour.
Measured: 1 Night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2008
- Study completionJan 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David M Rapoport, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750165
- Sponsor's protocol ID
- OSA CPAP; 254 Validation, NYU
- Status last verified
- Mar 2019
- First submitted
- 8 Sep 2008
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Norman RG, Rapoport DM, Ayappa I. Detection of flow limitation in obstructive sleep apnea with an artificial neural network. Physiol Meas. 2007 Sep;28(9):1089-100. doi: 10.1088/0967-3334/28/9/010. Epub 2007 Sep 5.
PubMed 17827656
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.
- ClinicalTrials.gov ID
- NCT00750165
- Acronym / sponsor ID
- OSA CPAP; 254 Validation, NYU
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 9 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Titration Night | Experimental | Device: SleepStyle 200 Auto Series CPAP HumidifierTreatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AHI >15 on the diagnostic portion of the study
- >18 years of age
Key exclusion criteria (5 listed)
- Significant Central Apnea
- Congestive Heart Failure
- Inability to give informed consent
- Patient intolerance to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
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 HumidifierAlso: HC254The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine | Device | Titration Night |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: 1 night
The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.
3 secondary outcomes
Percent of Time With Less Than 90% Oxygen Saturation
Time frame: 1 Night
Respiratory Disturbance Index (RDI)
Time frame: 1 Night
Arousal Index (AI)
Time frame: 1 Night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17827656Norman RG, Rapoport DM, Ayappa I. Detection of flow limitation in obstructive sleep apnea with an artificial neural network. Physiol Meas. 2007 Sep;28(9):1089-100. doi: 10.1088/0967-3334/28/9/010. Epub 2007 Sep 5.
- Sponsor websiteLink provided by the sponsor.
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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.
David M Rapoport, MD principal investigator
NYU School of Medicine
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 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 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: finished, as of the sponsor's last update on 9 Apr 2019. 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 9 Apr 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) (time frame: 1 night). 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 NCT00750165, which also lists 1 linked publication.
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 Apr 2019.