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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Tasman CPAP system

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2155
      • ResMed Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tasman CPAP	Device: Tasman CPAP system; Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.; Other Names: ResMed Tasman

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Klaus Schindhelm, ResMed

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: MA14010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No