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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: SleepStyle 200 Auto Series CPAP Humidifier

• Registration Number: NCT00697424
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-07
• Last Update Posted: 2008-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Contraindicated for CPAP use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SleepStyle 200 Auto Series CPAP Humidifier	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.

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	At the end of the sleep study.

Secondary Outcome Measures

Name	Time	Method
Respiratory Disturbance Index (RDI)	At the end of the sleep study (PSG)

Trial Locations

Locations (1)

Auckland Hospital, Adult Sleep & Ventilation Service, Auckland City Hospital; 🇳🇿 Auckland, New Zealand