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OpenTrials
Completed

NCT Number: NCT03948152

A Study to Determine Preferences Towards Interface Products

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.

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Key information

Conditions

Sleep Disorder; Breathing-Related Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Disease Specialists, PA, d/b/a PDS Research, Kissimmee, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

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.

Mask Advice Tool

Other

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 outcomes

  1. Proportion of participants requiring one or more mask re-fits

    Time frame: 90 days

    Proportion of participants in each arm requiring one or more mask re-fits.

Secondary outcomes

  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 CPAP therapy

    Time frame: 90 days

    Adherence to CPAP therapy as determined by average hours of use

  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 complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.

  11. Subjective preference rated by clinicians

    Time frame: 90 days

    Clinicians will complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2019
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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