An interventional study of SleepStyle 200 Auto Series CPAP Humidifier in Sleep Apnea, Obstructive, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 32 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: HC254
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.
Time frame: 1 night
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%.
Time frame: 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.
Time frame: 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.
Time frame: 1 Night
| Milestone | Titration Night |
|---|---|
| Started | 32 |
| Completed | 21 |
| Not completed | 11 |
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.
| events per hour | Titration Night |
|---|---|
| Apnea Hypopnea Index (AHI) | 2.4 (0.0 to 8.6) |
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%.
| percentage of total sleep time | Titration Night |
|---|---|
| Percent of Time With Less Than 90% Oxygen Saturation | 1.4 (0 to 24.7) |
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.
| events per hour | Titration Night |
|---|---|
| Respiratory Disturbance Index (RDI) | 7.1 (1.5 to 13.2) |
The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour.
| events per hour | Titration Night |
|---|---|
| Arousal Index (AI) | 16.2 (4.9 to 32.9) |
Collected over 1 night. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Titration Night | 0/21 (0%) | 0/21 (0%) | 6/21 (28.6%) |
| Event | Titration Night |
|---|---|
| Disruption of Sleep Due to Lab EnvironmentInvestigations | 4/21 |
| Mask DiscomfortRespiratory, thoracic and mediastinal disorders | 1/21 |
| Difficulty Exhaling Due to PressureRespiratory, thoracic and mediastinal disorders | 1/21 |
| Age, Continuous(years) | Titration Night |
|---|---|
| Mean | 51 (29 to 76) |
| Sex: Female, Male(Participants) | Titration Night |
|---|---|
| Female | 0 |
| Male | 21 |
| Race and Ethnicity Not Collected(Participants) | Titration Night |
|---|
| Region of Enrollment(participants) | Titration Night |
|---|---|
| United States | 21 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Fisher and Paykel Healthcare