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Salt Lake mask system · 1 trial · 1 indication
Participants in the study will complete a subjective assessment of the levels of seal, comfort, stability and overall Performance of Salt Lake Mask System in use.
| Arm | Type | Description |
|---|---|---|
| Salt Lake mask system | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Salt Lake mask system | DEVICE | Study participants will Salt Lake mask system for 1 week in place of their current mask system. |
Inclusion Criteria: * Patients willing to give written informed consent * Patients who can read and comprehend English * Patients using the Swift FX mask system * Patients who can trial the mask for 7 nights * Patients who have used PAP therapy for a minimum of 6 months. Exclusion Criteria: * Pat...
The Salt Lake mask system is a medical device used for Obstructive Sleep Apnea. It is a mask system designed for patients with this condition. The device is being developed by ResMed Inc. and has been evaluated in a clinical trial in Australia.
ResMed Inc. (NYSE: RMD) makes the Salt Lake mask system. The company is developing this mask system for Obstructive Sleep Apnea. ResMed is the developer of the device and has conducted a clinical trial to evaluate its performance.
The Salt Lake mask system is in Phase 2 clinical development. It is an investigational device and is not yet approved. A Phase 2 trial has been completed to evaluate its performance in patients with Obstructive Sleep Apnea.
The Salt Lake mask system has one completed clinical trial, NCT01395693, titled "Performance of the Salt Lake Mask System." This Phase 2 study enrolled 20 participants with Obstructive Sleep Apnea in Australia. The trial was uncontrolled and not randomized or double-blinded.
The Salt Lake mask system is not FDA approved. It is an investigational device currently in Phase 2 clinical development. A completed trial, NCT01395693, evaluated its performance, but the device has not received regulatory approval.