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The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

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: NCT03725839
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Obstructive Sleep Apnea Device: F&P Interface Not Applicable

Detailed Description:
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Arm
F&P Interface will be used by OSA participants in-home for 2 weeks.
Device: F&P Interface
F&P Interface to be used for OSA therapy




Primary Outcome Measures :
  1. Trial Mask usability [ Time Frame: 14 ± 4 days in home ]
    Questionnaire on ease-of-use (very easy to very difficult) Subjective

  2. Trial mask Performance [ Time Frame: 14 ± 4 days in home ]
    Questionnaire on performance (very good to very poor)- Subjective


Secondary Outcome Measures :
  1. Trial mask Reliability [ Time Frame: 5 months and 2 weeks in home ]
    Questionnaire on reliability - Subjective

  2. Trial mask performance measured in L/min [ Time Frame: 14 ± 4 days in home ]
    Objective leak data from PAP device



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (18+ years of age)
  • Able to give written consent
  • AHI ≥ 5 on diagnostic night
  • Either prescribed APAP, CPAP or Bi-level PAP for OSA

Exclusion Criteria:

  • Inability to give written consent
  • Anatomical or physiological conditions making PAP therapy inappropriate
  • Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
  • Current diagnosis of respiratory disease or 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): NCT03725839


Locations
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New Zealand
Hawkes Bay Fallen Soldiers' Memorial Hospital
Hastings, Hawkes Bay, New Zealand, 4120
Fisher & Paykel Healthcare
Auckland, New Zealand, 2013
Well Sleep
Wellington, New Zealand, 6035
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Bhavi Ogra Clinical Manager

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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT03725839    
Other Study ID Numbers: CIA-249
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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