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Vent Flow Study of Prototype Nasal CPAP Mask (GVFECT)

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ClinicalTrials.gov Identifier: NCT02805777
Recruitment Status : Withdrawn (Study not required due to change in device)
First Posted : June 20, 2016
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
ResMed

Brief Summary:
As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Device: CPAP mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Vent Flow Study of Prototype Nasal CPAP Mask System
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Washing procedure 1
this group will apply washing technique 1
Device: CPAP mask
A new vent CPAP mask system will be used in this trial

Experimental: Washing procedure 2
this group will apply washing technique 2
Device: CPAP mask
A new vent CPAP mask system will be used in this trial




Primary Outcome Measures :
  1. Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial. [ Time Frame: 12 weeks ]

    The mask system will be flow tested after use when returned by the participant at each scheduled visit. The flow of the mask system will be recorded as per the mask to flow procedure of ISO17510 Sleep apnoea breathing therapy - Part 2: Annex B Exhaust flow test procedure.

    The results will be reported as an average flow in LPM. Results will be presented graphically with average flow on the vertical axis and use time (weeks) on the horizontal axis. This will allow us to assess any changes in vent flow over time.



Secondary Outcome Measures :
  1. Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed [ Time Frame: 12 weeks ]
  2. Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked. [ Time Frame: 12 weeks ]
    This data will be collected from questionnaires completed in the home environment during use of the mask. The outcome will be descriptive in nature. When there is a single rating which expresses how good the product is, we will set a criterion value C which will be regarded as acceptable. The statistical test used will be the Wilcoxon signed ranks method.

  3. Bioburden quantification by laboratory testing of venting components at end of trial [ Time Frame: 12 weeks ]

    The viable microorganisms present on the mask system upon completion of the trial will be counted using ISO 11737 Sterilisation of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products.

    Results will be presented as total quantity of Microorganism (log10 CFU) per diffuser.




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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:

  • Participants willing to give written informed consent
  • Participants who can read and comprehend English
  • Participants using APAP for >6 months
  • Participants who are willing to use the mask system for the 3 month duration of the trial.
  • Participants who are over 18 years of age
  • Participants who currently use a nasal mask system

Exclusion Criteria:

  • Participants not willing to give written informed consent
  • Participants who cannot read and comprehend English
  • Participants using an inappropriate mask system
  • Participants on a Bilevel or ASV therapy
  • Participants who are pregnant
  • Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer lung injury; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection
  • Participants or whose bed partner with implantable metallic implants in the head, neck and chest region affected by magmetic fields (Non-ferrous implants may be acceptable)
  • Participants that weight <30 kg
  • Participants who are unsuitable to participate in the study in the opinion of the researcher

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): NCT02805777


Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Klaus Schindhelm, PhD ResMed/The University of New South Wales
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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02805777    
Other Study ID Numbers: MA300516
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no sharing plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases