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

NCT ID: NCT01171066

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-10-31

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

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tasman CPAP

Group Type: EXPERIMENTAL

Tasman CPAP system

Intervention Type: DEVICE

Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.

Interventions

Tasman CPAP system

Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.

Intervention Type: DEVICE

Other Intervention Names

ResMed Tasman

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaus Schindhelm

Role: PRINCIPAL_INVESTIGATOR

ResMed

Locations

ResMed Ltd

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

MA14010

Identifier Type: -

Identifier Source: org_study_id