Comparison of Breathing Events Detected by the SleepStyle 200 Auto Continuous Positive Airway Pressure (CPAP) Device to Attended Polysomnography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697424
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : December 9, 2008
Information provided by:
Fisher and Paykel Healthcare

Brief Summary:

Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health consequences include impaired cognitive functioning, quality of life, mood, and increased cardiovascular disease risk. Epidemiological studies have demonstrated that increased morbidity and mortality in a dose response manner with increasing severity of sleep disordered breathing.

The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which consists of pressurized air applied to the nose via a mask. Generally a single, optimal pressure is prescribed for a patient based on a full night or partial night study during which the pressure is adjusted by a technician until all sleep disordered breathing (SDB) events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal.

Due to low compliance it has become common for healthcare providers to follow up subject therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare providers can use this reported data to make appropriate treatment decisions. For this reason the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto adjusting CPAP which stores comprehensive compliance data. The aim of this study is to compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG in detecting sleep disordered breathing.

Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of sleep disordered breathing.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: SleepStyle 200 Auto Series CPAP Humidifier Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Methods to Detect Respiratory Irregularities in Obstructive Sleep Apnea (OSA)
Study Start Date : May 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 1
All subjects will be placed on continuous positive airway pressure (CPAP) therapy during a full night sleep study or polysomnography (PSG). The subjects will spend 2 hours on sub-therapeutic CPAP 4 cmH2O of pressure and the remainder on there therapeutic pressure. Values reported on the device will be compared to scored values from manual scoring of the sleep study.
Device: SleepStyle 200 Auto Series CPAP Humidifier
The device will record on internal software perceived sleep disordered breathing events. Events will also be scored manually on the polysomnography (PSG. Results will then be compared.

Primary Outcome Measures :
  1. Apnea Hypopnea Index [ Time Frame: At the end of the sleep study. ]

Secondary Outcome Measures :
  1. Respiratory Disturbance Index (RDI) [ Time Frame: At the end of the sleep study (PSG) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Apnea Hypopnea Index (AHI) >15 from diagnostic night
  • ≥18 years of age

Exclusion Criteria:

  • Contraindicated for CPAP use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697424

New Zealand
Auckland Hospital, Adult Sleep & Ventilation Service, Auckland City Hospital
Auckland, New Zealand, 1010
Sponsors and Collaborators
Fisher and Paykel Healthcare
Principal Investigator: Jessica R Hayward, Msc Fisher & Paykel Healthcare

Additional Information:
Responsible Party: Jessica Hayward, Fisher & Paykel Healthcare Identifier: NCT00697424     History of Changes
Other Study ID Numbers: FPHHC254a
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: December 9, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases