Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System

Study Overview
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Brief Summary
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Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.

Detailed Description
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Obstructive Sleep Apnoea (OSA) is a condition characterised by partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit. Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up. The purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device. Aim To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape) To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use

Official Title
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Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Tasman CPAP system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients willing to give written informed consent Patients who can read and comprehend English Patients being treated for OSA for >6 months Patients using a ResMed nasal mask system Patients who can trial the trial mask for 7 nights Exclusion Criteria Patients not willing to give written informed consent Patients who can not read and comprehend English Patients being treated for OSA for <6 months Patients using an inappropriate mask system Patients using Bilevel flow generators Patients who are not using CPAP between 7 and 13 cmH2O Patients who are pregnant Patients who cannot trial the trial mask for 7 nights Patients with a hearing impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tasman CPAP<br> | Device: Tasman CPAP system<br>* Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.<br>* Other names: ResMed Tasman;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the usability of the Tasman CPAP system |  | 1 week |