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OpenTrials
Completed

NCT Number: NCT00750165

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Sleep Disorders Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: HC254

Primary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: 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 outcomes

  1. Percent of Time With Less Than 90% Oxygen Saturation

    Time frame: 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%.

  2. Respiratory Disturbance Index (RDI)

    Time frame: 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.

  3. Arousal Index (AI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2008
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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