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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171066
• Other study ID #: MA14010
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Australia	ResMed Ltd	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)		1 week
Secondary	To assess the usability of the Tasman CPAP system		1 week