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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: SleepStyle 200 Auto Series CPAP Humidifier

• Registration Number: NCT00750165
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Status Verified: 2019-03
• Results First Submitted: 2019-03-20
• Results First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Results First Posted: 2019-04-09
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Titration Night	SleepStyle 200 Auto Series CPAP Humidifier	Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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%.

Trial Locations

Locations (1)

NYU Sleep Disorders Center; 🇺🇸 New York, New York, United States