Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnoea.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorResMed

About this trial

Each participant will wear a wearable PAP device, tethered to a released PAP device for up to 7 nights. Objectives include collecting and evaluating participants feedback on seal, comfort and usability of the wearable PAP device.

Eligibility criteria

Qualifiers

Participants who ≥ 18 years of age

Participants who can trial the APL mask system for up to 7 nights

Participants willing and able to complete the specified tasks

Participants being treated for Obstructive Sleep Apnea (OSA) for ≥ 3 months*

Disqualifiers

Participants using Bilevel flow generators

Participants who are or may be pregnant

Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.

Participants (or participants bed partners) with active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).

Trial design

Treatments tested in this trial

  • Positive Airway Pressure

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators