Back to resultsVent Flow Study of Prototype Nasal CPAP Mask (GVFECT)
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Washing procedure 1
Washing procedure 2
Arm Description
this group will apply washing technique 1
this group will apply washing technique 2
Outcomes
Primary Outcome Measures
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.
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
Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed
Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked.
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.
Bioburden quantification by laboratory testing of venting components at end of trial
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02805777
Brief Title
Vent Flow Study of Prototype Nasal CPAP Mask
Acronym
GVFECT
Official Title
Long Term Vent Flow Study of Prototype Nasal CPAP Mask System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study not required due to change in device
Study Start Date
May 1, 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Washing procedure 1
Arm Type
Experimental
Arm Description
this group will apply washing technique 1
Arm Title
Washing procedure 2
Arm Type
Experimental
Arm Description
this group will apply washing technique 2
Intervention Type
Device
Intervention Name(s)
CPAP mask
Intervention Description
A new vent CPAP mask system will be used in this trial
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed
Time Frame
12 weeks
Title
Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked.
Description
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.
Time Frame
12 weeks
Title
Bioburden quantification by laboratory testing of venting components at end of trial
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, PhD
Organizational Affiliation
ResMed/The University of New South Wales
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no sharing plan.
Learn more about this trial
Vent Flow Study of Prototype Nasal CPAP Mask
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