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

This study has been completed.
Sponsor:
Information provided by:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT00697424
First received: June 11, 2008
Last updated: December 7, 2008
Last verified: December 2008
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Methods to Detect Respiratory Irregularities in Obstructive Sleep Apnea (OSA)

Resource links provided by NLM:


Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • Apnea Hypopnea Index [ Time Frame: At the end of the sleep study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Respiratory Disturbance Index (RDI) [ Time Frame: At the end of the sleep study (PSG) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindicated for CPAP use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697424

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

Additional Information:
No publications provided

Responsible Party: Jessica Hayward, Fisher & Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00697424     History of Changes
Other Study ID Numbers: FPHHC254a, AKY/03/07/166
Study First Received: June 11, 2008
Last Updated: December 7, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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 17, 2014