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OpenTrials
Completed

NCT Number: NCT01575210

Assessment of the Performance of a New Reduced Noise Mask Vent

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.

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Key information

Conditions

Obstructive Sleep Apnoea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ResMed Centre for Healthy Sleep

Sydney, New South Wales, 2153, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP mask

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2012
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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