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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Tasman CPAP system

• Registration Number: NCT01171066
• Lead Sponsor: ResMed

Brief Summary

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

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

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tasman CPAP	Tasman CPAP system	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess the usability of the Tasman CPAP system	1 week

Trial Locations

Locations (1)

ResMed Ltd; 🇦🇺 Sydney, New South Wales, Australia