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A Study to Determine Preferences Towards Interface Products

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ClinicalTrials.gov Identifier: NCT03948152
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

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.

Condition or disease Intervention/treatment Phase
Sleep Disorder; Breathing-Related Other: Standard of Care Other: Mask Advice Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Active Comparator: Standard of Care Other: Standard of Care
Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care.

Experimental: Mask Advice Tool Other: Mask Advice Tool
Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool.




Primary Outcome Measures :
  1. Number of Mask Re-fits [ Time Frame: 90 days ]
    Average number of mask re-fits in each arm


Secondary Outcome Measures :
  1. Number of masks tried during the initial fitting visit [ Time Frame: 90 days ]
    Number of masks tried during the initial fitting visit in each arm.

  2. Number of masks tried after going home with the first mask [ Time Frame: 90 days ]
    Number of masks tried after going home with the first mask in each arm.

  3. Amount of time to fit each mask [ Time Frame: 90 days ]
    Amount of time to fit each mask in each arm.

  4. Number of sleep clinic or sleep center callbacks related to mask fitting issues [ Time Frame: 90 days ]
    Number of sleep clinic or sleep center callbacks related to mask fitting issues in each arm.

  5. The amount of time spent on these calls to resolve mask issues [ Time Frame: 90 days ]
    The amount of time spent on these calls to resolve mask issues in each arm.

  6. Number of unplanned visits to adjust current mask or fit with another masks [ Time Frame: 90 days ]
    Number of unplanned visits to adjust current mask or fit with another masks in each arm.

  7. Duration of the unplanned visits [ Time Frame: 90 days ]
    Duration of the unplanned visits in each arm.

  8. Adherence to Continuous positive airway pressure (CPAP) therapy [ Time Frame: 90 days ]
    Adherence to CPAP therapy as determined by average hours of use per Centers for Medicare and Medicaid Services (CMS) criteria.

  9. Mask leak for chosen masks [ Time Frame: 90 days ]
    Mask leak for chosen masks in each arm.

  10. Subjective preference rated by patients [ Time Frame: 90 days ]

    Patients will rate 8 questions based off their post fit experience on a 0 to 10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely.

    Patients will be able to answer on a score of 0 to 80 their mask preference in each arm with each mask.


  11. Subjective preference rated by clinicians [ Time Frame: 90 days ]

    Clinicians will rate 8 questions based off their post fit experience on a 0 to 10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely.

    Clinicians will be able to answer on a score of 0 to 80 their mask preference in each arm with each mask for each patient.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948152


Contacts
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Contact: Erin Kankoski 412-542-3776 erin.kankoski@philips.com

Locations
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United States, Florida
Pulmonary Disease Specialists, PA, d/b/a PDS Research Recruiting
Kissimmee, Florida, United States, 34741
Contact: Thomas W O'Brien    407-933-1221      
United States, Maryland
Center for Sleep and Wake Disorders Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Robby Pederson    301-654-5665    robert@sleep.doc   
Principal Investigator: Helene Emsellem, MD         
United States, Ohio
Pullmonary Rehabilition Associates Recruiting
Youngstown, Ohio, United States, 44512
Contact: Marijo Shuntich       marijos@secondwindrehab.com   
Principal Investigator: Alan Cropp, MD         
United States, Pennsylvania
Berks Schuylkill Respiratory Specialists, Ltd. Recruiting
Reading, Pennsylvania, United States, 19610
Contact: Daron Kahn    610-685-5864      
United States, South Carolina
Bogan Sleep Consultants, LLC Recruiting
Columbia, South Carolina, United States, 29201
Contact: Kim Bowyer    803-251-3093      
Sponsors and Collaborators
Philips Respironics

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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT03948152     History of Changes
Other Study ID Numbers: SRC-SLE(PI)-CP-2018-10129
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philips Respironics:
Sleep Apnea
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders