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N/A N=32 Treatment

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

Sleep Apnea, Obstructive

Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Apnea Hypopnea Index (AHI) — 2.4 events per hour

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SleepStyle 200 Auto Series CPAP Humidifier (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Fisher and Paykel Healthcare
Primary completion
Jan 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Apnea Hypopnea Index (AHI)
2.4
SECONDARY
Percent of Time With Less Than 90% Oxygen Saturation
1.4
SECONDARY
Respiratory Disturbance Index (RDI)
7.1
SECONDARY
Arousal Index (AI)
16.2

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00750165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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