In-Lab Assessment of a newly developed Continuous Positive Airway Pressure Device for Obstructive Sleep Apnea Treatment in New Zealand.

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12613001282774
• Lead Sponsor: Hanie Yee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Aged 18+
Diagnosed with OSA by a practicing sleep physician
AHI > 5 from diagnostic night

Exclusion Criteria

Patients with a known history ofCerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus

Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or for patients who have an increased risk of pneumothorax, such as those with bullous lung disease

Patient with bypassed upper airway

Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)

Patients with obesity hypoventilation syndrome or congestive heart failure

Patients that require supplemental oxygen with their CPAP device

Patients with implanted electronic medical devices (e.g. cardiac pacemakers)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This trial is to inform product development teams of the performance, safety, reliability and patient preference in regards to the investigation device. The efficacy will be scored by the PSG (AHI*, oxygen desaturation levels). Subjective patient data will also be gathered in the form of a questionnaire which will ask patients about their experience with the investigation device. <br><br>* AHI is defined as the Apnea Hypopnea Index. It is an index of sleep apnea severity that combines apneas and hypopneas (partial obstruction of upper airway). Calculated by dividing the number of events by the number of hours of sleep.[One night of therapy (in-lab). Patients will be monitored continually throughout the night by a PSG technician, and questionnaires will be completed in the morning immediately following the study. Recorded PSG studies will be scored and assessed after the night of therapy. ]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome for this trial would be to inform product development of potential errors and bugs before retail product launch to the market. Potential errors may include device failing to power-on, device failing to maintain therapeutic pressure. [One night of therapy (in-lab). Device logs will be monitored throughout the night by a device engineer, and recorded logs will be assess after the night of therapy. ]