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

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Tasman CPAP system

Study type: Interventional

Funder types: Industry

Identifiers

NCT01171066

MA14010

Details and patient eligibility

About

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.

Full 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

Enrollment: 57 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Tasman CPAP

Experimental group

Treatment:

Device: Tasman CPAP system