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Assessment of the Performance of a New Reduced Noise Mask Vent

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ClinicalTrials.gov Identifier: NCT01575210
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
ResMed

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting
Study Start Date : June 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Experimental: Group A_ 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: Group B_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. The apnoea/hypopnoea index (AHI) will be recorded and analysed. [ Time Frame: 12 weeks ]
    Breathing disruption events per hour of sleep will be measured and analysed


Secondary Outcome Measures :
  1. The level of comfort patients experience while using the new mask vent [ Time Frame: 12 weeks ]
    Patients will complete a questionnaire regarding the noise of the new vent

  2. Patient's and bed partner's perceptions of the mask vent [ Time Frame: 12 weeks ]
    Patients partners will complete a questionnaire regarding the noise of the mask vent



Information from the National Library of Medicine

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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:

  • 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

Exclusion Criteria:

  • 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

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): NCT01575210


Locations
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Australia, New South Wales
ResMed Centre for Healthy Sleep
Sydney, New South Wales, Australia, 2153
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: NCT01575210    
Other Study ID Numbers: MA210212
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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