Clinical trial NCT03948152: A Study to Determine Preferences Towards Interface Products
Official title: A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder; Breathing-Related
Keywords: Sleep Apnea
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 310
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days documented.


Eligibility criteria: Inclusion Criteria:

* Adult Volunteers (ages 21-85)
* Willing and able to provide informed consent
* Able to follow instructions
* Able to read and speak in English as their primary language
* Currently diagnosed with Sleep Apnea through an in-lab sleep (polysomnography (PSG)) or home sleep testing, but has not started therapy and/or been fit with a mask.

Exclusion Criteria:

* Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, cribriform plate abnormalities, and prior history of head trauma that has resulted in current cognitive dysfunction.
* Prescribed an Adaptive Servo Ventilation (ASV) device
* The presence of physical or mental limitations that would limit the ability to test the mask.
* Obstructive Sleep Apnea (OSA) diagnosis achieved through a split night sleep study
* Known allergy to silicone
* Unique facial features (i.e. deformities of the face and/or head, piercings, etc) that could interfere with the use of masks.
* Employee of Philips or spouse of a Philips employee
* Currently participating in another interventional research study or planned participation in another interventional research study during the trial period (by self-report)
* Surgery involving the eyes, ears, nose, sinuses, or upper airway within the last 90 days.
* Planned surgical procedures involving the head, neck, face (eyes, ears, nose), or lung during the trial period.
* Uncontrolled or poorly managed gastroesophageal reflux
* Impaired cough reflex
* Untreated or symptomatic hiatal hernia
* Untreated glaucoma
* Untreated chronic dry eyes
* Unable to remove the sleep apnea mask without the assistance of others
* Use of prescription drugs that induce vomiting

Primary outcomes:
measure: Proportion of participants requiring one or more mask re-fits
timeFrame: 90 days
Secondary outcomes:
measure: Number of masks tried during the initial fitting visit
timeFrame: 90 days
measure: Number of masks tried after going home with the first mask
timeFrame: 90 days
measure: Amount of time to fit each mask
timeFrame: 90 days
measure: Number of sleep clinic or sleep center callbacks related to mask fitting issues
timeFrame: 90 days
measure: The amount of time spent on these calls to resolve mask issues
timeFrame: 90 days
measure: Number of unplanned visits to adjust current mask or fit with another masks
timeFrame: 90 days
measure: Duration of the unplanned visits
timeFrame: 90 days
measure: Adherence to CPAP therapy
timeFrame: 90 days
measure: Mask leak for chosen masks
timeFrame: 90 days
measure: Subjective preference rated by patients
timeFrame: 90 days
measure: Subjective preference rated by clinicians
timeFrame: 90 days
Other outcomes:
Locations:
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialists, PA, d/b/a PDS Research
state: Florida
city: Chevy Chase
country: United States
facility: Center for Sleep and Wake Disorders
state: Maryland
city: Youngstown
country: United States
facility: Pullmonary Rehabilition Associates
state: Ohio
city: Reading
country: United States
facility: Berks Schuylkill Respiratory Specialists, Ltd.
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
Study officials:
References: