Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Sleep Apnea, Obstructive Clinical Trial

Official title:

Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750165
• Other study ID #: OSA CPAP; 254 Validation, NYU
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: January 2008

Study information

• Verified date: March 2019
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	NYU Sleep Disorders Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Sep 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 night
Secondary	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%.	1 Night
Secondary	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.	1 Night
Secondary	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.	1 Night

External Links

•   Sponsor website