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Completed

NCT Number: NCT01847846

Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users

BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask.

The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time.

ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy.

AIMS

The aims of the study are:

1. To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks 2. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask over a period of 8 weeks 3. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask versus an available mask

It is hypothesised that:

1. The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks. 2. The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks. 3. Compared to the existing mask, the new mask provides a higher degree of comfort, seal and stability and improves user compliance. The new mask also maintains efficacy, and maintains or reduces leak compared to the current masks.

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Key information

Conditions

Obstructive Sleep Apnea 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ResMed Ltd

Bella Vista, 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

  • At least 18 yrs old
  • Diagnosed with obstructive sleep apnoea
  • Been using CPAP therapy for at least 6 months

Exclusion criteria

  • Has a lung disease/condition
  • Using bilevel therapy
  • Is unable to participate for the duration of the study

Treatment and study plan

CPAP mask - prototype

Device

prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings.

Other names: PAP mask

Primary outcomes

  1. To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks

    Time frame: up to 8 weeks of use

    The mask is for single user use only. The participants will be instructed not to wash or clean the material for the duration of the study. The mask will be returned in a sealed bag and sent off for testing within 24 hrs after the trial.

Secondary outcomes

  1. Measure and compare mask efficacy over a period of 8 weeks

    Time frame: After 2, 4, 6 and 8 weeks of use

    The efficacy variables that will be measured and compared at each time point are:

    Apnea Hypopnea Index (AHI; the number of apneas and hypopneas per hour), mask leak, number of hours of use per night, and user compliance will be measured

Other outcomes

  1. Measure and compare mask performance over a period of 8 weeks

    Time frame: after 2, 4, 6 and 8 weeks of use

    Mask performance will be subjectively assessed by the user over a period of 8 weeks.

    Varibles which will be measured are:

    • Comfort
    • Mask seal
    • Mask stability
    • The occurence of red marks

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 7, 2013
Registry last updated
Feb 4, 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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