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

NCT00697424 | Completed DMC

• 2 other identifiers: FPHHC254aAKY/03/07/166
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index

  At the end of the sleep study.

Secondary Outcomes (1)

• Respiratory Disturbance Index (RDI)

  At the end of the sleep study (PSG)

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

SleepStyle 200 Auto Series CPAP Humidifier DEVICE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindicated for CPAP use

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Auckland Hospital, Adult Sleep & Ventilation Service, Auckland City Hospital

Auckland, 1010, New Zealand

Location

Related Links

• Sponsors web site

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jessica R Hayward, Msc

  Fisher & Paykel Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 9, 2008

Record last verified: 2008-12

Locations

NZ (1)