Assessment of the Performance of a New Reduced Noise Mask Vent

NCT01575210 | Completed DMC

• 1 other identifier: MA210212
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.

Conditions

Obstructive Sleep Apnoea (OSA)

Outcome Measures

Primary Outcomes (1)

• The apnoea/hypopnoea index (AHI) will be recorded and analysed.

  Breathing disruption events per hour of sleep will be measured and analysed

  12 weeks

Secondary Outcomes (2)

• The level of comfort patients experience while using the new mask vent

  12 weeks

• Patient's and bed partner's perceptions of the mask vent

  12 weeks

Study Arms (2)

Group A_ washing procedure 1

EXPERIMENTAL

This group will apply washing technique 1.

Device: CPAP mask

Group B_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.

Group A_ washing procedure 1

Eligibility Criteria

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

You may qualify if:

• Subjects who are using ResMed mask
• Subjects willing to provide written informed consent
• Subjects who have been treated for OSA \> 6 months
• Subjects who can read and comprehend English
• Subjects ≥ 18 years old
• Subjects who are using a ResMed S8 or S9 device

You may not qualify if:

• Patients who are pregnant
• Patient on bi level treatment
• Patients being treated for OSA \< 6 months
• Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (\<2 years ago) case of pneumonia or lung infection; lung injury).
• Patients who are deemed unsuitable by the researcher due to the following reasons:
• They do not comprehend English
• They are unable to provide written informed consent
• They are physically unable to comply with the protocol

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

ResMed Centre for Healthy Sleep

Sydney, New South Wales, 2153, Australia

Location

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: March 27, 2012
• First Posted: April 11, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

AU (1)