Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tasman CPAP
Intervention: Tasman CPAP system (Device)
Outcomes
Primary Outcomes
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
Time Frame: 1 week
Secondary Outcomes
- To assess the usability of the Tasman CPAP system(1 week)