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

NCT00750165 | Completed Results DMC

• 1 other identifier: OSA CPAP; 254 Validation, NYU
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea; Humidification; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percent of Time With Less Than 90% Oxygen Saturation

  1 Night

• Respiratory Disturbance Index (RDI)

  1 Night

• Arousal Index (AI)

  1 Night

Study Arms (1)

Titration Night

EXPERIMENTAL

Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device

Device: SleepStyle 200 Auto Series CPAP Humidifier

Interventions

SleepStyle 200 Auto Series CPAP Humidifier DEVICE

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

Titration Night

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHI \>15 on the diagnostic portion of the study
• \>18 years of age

You may not qualify if:

• Significant Central Apnea
• Congestive Heart Failure
• Inability to give informed consent
• Patient intolerance to CPAP
• Anatomical or physiological conditions making CPAP therapy inappropriate

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

NYU Sleep Disorders Center

New York, New York, 10016, United States

Location

Related 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. doi: 10.1088/0967-3334/28/9/010. Epub 2007 Sep 5.

  PMID: 17827656 BACKGROUND

Related Links

• Sponsor website

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Clinical Research Scientist
• Organization: Fisher and Paykel Healthcare

cpaptrial@fphcare.co.nz

+64 9 574 0123

Study Officials

• David M Rapoport, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 10, 2008
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-03

Locations

US (1)