Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726346
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Trial Mask Not Applicable

Detailed Description:
Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F&P trial mask for use in home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 2 weeks of the beginning of the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Trial Mask

Participants will be placed on this arm for a total of 14

+- 4 days from visit 2. Participants will be using the trial mask during this treatment arm

Device: Trial Mask
Experimental Trial Mask




Primary Outcome Measures :
  1. Trial Mask Acceptability [ Time Frame: 14±4 days in home ]
    Determined from questionnaires-Subjective

  2. Trial Mask Comfort [ Time Frame: 14±4 days in home ]
    Determined from questionnaires-Subjective

  3. Trial Mask Treatment Performance-Subjective [ Time Frame: 14±4 days in home ]
    Determined from questionnaires-Subjective


Secondary Outcome Measures :
  1. Trial Mask Treatment Performance-Objective [ Time Frame: 14±4 days in home ]
    Objective data recorded from PAP device- Objective



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (22+ years of age)
  • Able to give informed consent
  • Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
  • Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
  • Fluent in spoken and written English
  • Existing OSA mask user

Exclusion Criteria:

  • Inability to give informed consent
  • Participant intolerant to PAP
  • Anatomical or physiological conditions making PAP therapy inappropriate
  • Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
  • Pregnant or may think they are pregnant.

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): NCT03726346


Locations
Layout table for location information
United States, Florida
Pulmonary Disease Specialists
Orlando, Florida, United States, 34741
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
Layout table for investigator information
Study Director: Catherine Goodwin Research Director
Principal Investigator: Thomas O'Brien, MD Pulmonologist

Layout table for additonal information
Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT03726346     History of Changes
Other Study ID Numbers: CIA 243
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases