Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT06535932
Eligibility Criteria:
Inclusion Criteria:
* Aged 21-85 years (inclusive)
* Weight \>66 pounds/30 kg
* Established on PAP for ≥90 days at the time of consent
* Currently prescribed and using fixed pressure, Auto CPAP, or Bi-Level therapy on a regular basis (average PAP usage of ≥4 hours/night, ≥ 4 days per week for ≥3 months)
* Currently using a Full-Face mask
* Able to read, write, speak and understand English
* Willing and able to provide informed consent
* Willing and able to follow instructions and complete all activities required by the study
* Able to remove a sleep apnea mask without assistance
Exclusion Criteria:
* Currently using a Philips Respironics Amara View FFM or ResMed AirFit F40 FFM
* Allergy to silicone
* Allergy to latex
* Unique facial features (i.e., deformities of the face and/or head, piercings, etc.) that could interfere with the therapeutic use of this type of mask
* Employee or living with a family member who works for Philips or any company that designs, sells, or manufactures sleep-related products.
* Prescribed oxygen at night or continuously
* Recent eye surgery or dry eyes
* Hiatal hernia
* Excessive reflux
* Impaired cough reflux
* Impaired cardiac sphincter function
* Using prescription drugs that induce vomiting
* Currently participating in another interventional research study or planned participation in another interventional clinical research study during the trial period
* Prescribed an ASV (adaptive servo-ventilation) device
* Prescribed mechanical ventilation
* Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, or cribriform plate abnormalities
* Any unstable medical condition (e.g., uncontrolled cardiac, lung, or neurological disease) or limitation that would affect the participant's ability to complete trial activities
* Experiencing any acute illness (e.g., acute sinusitis, ear or eye infections, upper respiratory infections, pharyngitis, bronchitis, pleurisy, pneumonia, or facial dermatitis) that would impact their ability to use the mask and/or PAP therapy during the trial
* Surgical procedures involving the head, neck, face (eyes, ears, nose), or lungs in the previous 90 days or taking place any time during the trial period
* Pregnant
* Advised by a health care provider to avoid magnets
* Patient or patient's household member, caregiver or bed partner in close vicinity currently using medical implants or medical devices that would be affected by magnets, including but not limited to:
* Pacemakers
* Implantable cardioverter defibrillators (ICD)
* Neurostimulators
* Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
* Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
* Aneurysm clips
* Embolic coils
* Intracranial aneurysm intravascular flow disruption devices
* Metallic cranial plates, screws, burr hole covers, and bone substitute devices
* Metallic splinters in the eye
* Ocular implants (e.g., glaucoma implants, retinal implants)
* Certain contact lenses with metal
* Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
* Magnetic denture attachments
* Metallic gastrointestinal clips
* Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
* Implantable ports and pumps (e.g., insulin/infusion pumps)
* Hypoglossal nerve stimulators
* Devices labeled as MR (Magnetic Resonance) unsafe
* Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
* PAP device is unknown, or they are using a recalled device that has not yet been remediated. Recalled devices include:
* DreamStation CPAP, Auto CPAP, or BiPAP
* DreamStation BiPAP, autoSV (ASV)
* DreamStation ST, AVAPS (Also known as DreamStation BiPAP AVAPS or DreamStation BiPAP S/T)
* DreamStation Go CPAP, APAP or Auto CPAP
* Dorma 400 or 500 CPAP or Auto CPAP
* System One ASV4
* System One (Q-Series) 50 series CPAP, Auto CPAP, or BiPAP
* System One (Q-Series) 60 series CPAP, Auto CPAP, or BiPAP
* C Series ASV, S/T, or AVAPS
* REMStar SE Auto CPAP
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT06535932
Study Brief:
Protocol Section:
NCT06535932