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

This study has been completed.
Sponsor:
Information provided by:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT00750165
First received: September 8, 2008
Last updated: September 10, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Sleep Apnea, Obstructive
Device: SleepStyle 200 Auto Series CPAP Humidifier
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.

Resource links provided by NLM:


Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI) [ Time Frame: 1 night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxygen saturation [ Time Frame: 1 Night ] [ Designated as safety issue: No ]
  • Sleep Efficiency [ Time Frame: 1 Night ] [ Designated as safety issue: No ]
  • Arousal Index (AI) [ Time Frame: 1 Night ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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 Name: HC254

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750165

Locations
United States, New York
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
  More Information

Additional Information:
Publications:
Responsible Party: Jessica Hayward, Fisher & Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00750165     History of Changes
Other Study ID Numbers: OSA CPAP; 254 Validation, NYU
Study First Received: September 8, 2008
Last Updated: September 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Fisher and Paykel Healthcare:
Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014