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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02805777
Other study ID # MA300516
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date December 2017

Study information

Verified date February 2021
Source ResMed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
CPAP mask
A new vent CPAP mask system will be used in this trial

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
ResMed

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
12 weeks
Secondary Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed 12 weeks
Secondary 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. 12 weeks
Secondary 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.
12 weeks
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