Vent Flow Study of Prototype Nasal CPAP Mask

NCT02805777 | Withdrawn

• 1 other identifier: MA300516
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (3)

• Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed

  12 weeks

• Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked.

  12 weeks

• Bioburden quantification by laboratory testing of venting components at end of trial

  12 weeks

Study Arms (2)

Washing procedure 1

EXPERIMENTAL

this group will apply washing technique 1

Device: CPAP mask

Washing procedure 2

EXPERIMENTAL

this group will apply washing technique 2

Device: CPAP mask

Interventions

CPAP mask DEVICE

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

Washing procedure 1; Washing procedure 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Klaus Schindhelm, PhD

  ResMed/The University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 20, 2016
• Study Start: May 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share