Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Titration Night Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device |
Device: SleepStyle 200 Auto Series CPAP Humidifier
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Apnea Hypopnea Index (AHI) [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.
Secondary Outcome Measures
- Percent of Time With Less Than 90% Oxygen Saturation [1 Night]
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%.
- Respiratory Disturbance Index (RDI) [1 Night]
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.
- Arousal Index (AI) [1 Night]
The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
AHI >15 on the diagnostic portion of the study
-
18 years of age
Exclusion Criteria:
-
Significant Central Apnea
-
Congestive Heart Failure
-
Inability to give informed consent
-
Patient intolerance to CPAP
-
Anatomical or physiological conditions making CPAP therapy inappropriate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Sleep Disorders Center | New York | New York | United States | 10016 |
Sponsors and Collaborators
- Fisher and Paykel Healthcare
Investigators
- Principal Investigator: David M Rapoport, MD, NYU School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- OSA CPAP; 254 Validation, NYU
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Titration Night |
|---|---|
| Arm/Group Description | Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device SleepStyle 200 Auto Series CPAP Humidifier: 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 |
| Period Title: Overall Study | |
| STARTED | 32 |
| COMPLETED | 21 |
| NOT COMPLETED | 11 |
Baseline Characteristics
| Arm/Group Title | Titration Night |
|---|---|
| Arm/Group Description | Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device SleepStyle 200 Auto Series CPAP Humidifier: 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 |
| Overall Participants | 21 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
51
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
21
100%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
21
100%
|
Outcome Measures
| Title | Apnea Hypopnea Index (AHI) |
|---|---|
| Description | 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. |
| Time Frame | 1 night |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Titration Night |
|---|---|
| Arm/Group Description | Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device SleepStyle 200 Auto Series CPAP Humidifier: 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 |
| Measure Participants | 21 |
| Mean (Full Range) [events per hour] |
2.4
|
| Title | Percent of Time With Less Than 90% Oxygen Saturation |
|---|---|
| Description | 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%. |
| Time Frame | 1 Night |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Titration Night |
|---|---|
| Arm/Group Description | Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device SleepStyle 200 Auto Series CPAP Humidifier: 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 |
| Measure Participants | 21 |
| Mean (Full Range) [percentage of total sleep time] |
1.4
|
| Title | Respiratory Disturbance Index (RDI) |
|---|---|
| Description | 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. |
| Time Frame | 1 Night |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Titration Night |
|---|---|
| Arm/Group Description | Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device SleepStyle 200 Auto Series CPAP Humidifier: 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 |
| Measure Participants | 21 |
| Mean (Full Range) [events per hour] |
7.1
|
| Title | Arousal Index (AI) |
|---|---|
| Description | The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour. |
| Time Frame | 1 Night |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Titration Night |
|---|---|
| Arm/Group Description | Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device SleepStyle 200 Auto Series CPAP Humidifier: 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 |
| Measure Participants | 21 |
| Mean (Full Range) [events per hour] |
16.2
|
Adverse Events
| Time Frame | 1 night | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Titration Night | |
| Arm/Group Description | Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device SleepStyle 200 Auto Series CPAP Humidifier: 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 | |
All Cause Mortality |
||
| Titration Night | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Serious Adverse Events |
||
| Titration Night | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Titration Night | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/21 (28.6%) | |
| Investigations | ||
| Disruption of Sleep Due to Lab Environment | 4/21 (19%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||
| Mask Discomfort | 1/21 (4.8%) | 1 |
| Difficulty Exhaling Due to Pressure | 1/21 (4.8%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Research Scientist |
|---|---|
| Organization | Fisher and Paykel Healthcare |
| Phone | +64 9 574 0123 ext 7044 |
| cpaptrial@fphcare.co.nz |
- OSA CPAP; 254 Validation, NYU