Clinical trial NCT06535932: Amara View Benchmarks Study
Official title: An Assessment of Patient Preference for the Amara View Full Face Mask Compared to the ResMed AirFit F40 -a Benchmark Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Keywords: Positive Airway Pressure Therapy
Minimal contact full face mask
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover
Primary purpose: TREATMENT

Brief summary: This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters. At the first study visit participants will be fitted with either the Amara View or the AirFit F40. The order in which participants will use the masks will be randomized. After the fitting and completion of informed consent, eligibility, and baseline questionnaires, participants will take home the first mask and use it with their prescribed PAP device for 15-days. After the first 15-day time period participants will return for their second visit. At this visit participants will return the first mask to the study team and complete a survey on the mask attributes. They will then be fitted with the second study mask and will be given the mask to take home and use with their prescribed PAP device for 15-days. At the end of the second 15-day trial period, participants will return for the third study visit. At this visit they will return the second mask and complete a mask attributes survey on the second mask.

Detailed description: Participants will be recruited via a sleep clinic contracted to recruit participants within the United States. Study staff will be responsible for assessment of inclusion and exclusion criteria. Scheduling will be conducted by the site. Participants who are willing to enroll will be scheduled for an in-person visit to provide informed consent and complete study procedures. During the baseline visit, review the Informed Consent Form (ICF) with the participant explaining and answering any questions the participant may have about the study. If the participant is willing to take part in the study, the ICF will be signed and dated by the participant and the site study representative obtaining consent. Those who provide consent will then complete the Demographics Questionnaire, Baseline Mask Survey, and Eligibility Questionnaire to confirm entry criteria. Participants will be asked to bring their prescribed mask and PAP device to Visit 1.At the initial visit, participants will undergo a fitting of the mask they are randomized to start the study with; either the Amara View or the AirFit F40 mask. Participants will be fit with mask sizes recommended by the clinician. The clinician will use the provided sizing gauges for the Amara View and AirFit F40 masks respectively. Once a mask size is selected for the first study mask, the participant will undergo short trials using his or her own PAP machine at therapeutic pressure, and an assessment of mask fit will be performed. If the participant's PAP device is not available, they will be fitted with the mask and will undergo short trials using a PAP device provided by the site. Participants may be fitted with up to three mask sizes for the mask. A Mask Fitting Survey will be used to capture the participant's prescribed pressure, mask (cushion/frame) sizes and fitting observations for the first study mask.

After the mask fitting, participants will be given the first study mask to take home. They will be encouraged to use the mask for the full 15-days of the first trial period. After the first 15-day trial period with the first study mask, participants will return to the site for their second study visit. Participants will be instructed to bring their PAP device and the first study mask to the visit. Participants will complete a mask attributes survey on the first study mask and then they will be fitted with the second study mask. Fitting procedures will follow the same procedure as described above in the baseline visit. After the mask fitting, participants will be given the second study mask to take home. They will be encouraged to use the mask for the full 15 days of the second trial period. After the second 15-day trial period with the second study mask, participants will return to the site for the third and final study visit. During this visit, participants will complete a mask-attributes survey on the second study mask and return all study product.

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

Primary outcomes:
measure: Patient preference on Mask Attributes
timeFrame: up to 35 days
measure: Difference in Ease of Use
timeFrame: up to 35 days
measure: Difference in Net Promotor Score
timeFrame: Up to 35 days
measure: Patient Preference
timeFrame: Up to 35 days
Secondary outcomes:
measure: Leak
timeFrame: up to 35 days
measure: Residual AHI
timeFrame: up to 35 days
measure: Air Pressure
timeFrame: up to 35 days
measure: Adherence to PAP Therapy
timeFrame: up to 35 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
affiliation: Clayton Sleep Institute
name: Joseph Ojile, MD
role: PRINCIPAL_INVESTIGATOR
References: