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

NCT ID: NCT00750165

Last Updated: 2019-04-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-01-31

Brief Summary

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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

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Titration Night

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

Group Type EXPERIMENTAL

SleepStyle 200 Auto Series CPAP Humidifier

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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HC254

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M Rapoport, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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NYU Sleep Disorders Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17827656 (View on PubMed)

Related Links

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http://fphcare.com

Sponsor website

Other Identifiers

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OSA CPAP; 254 Validation, NYU

Identifier Type: -

Identifier Source: org_study_id

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