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Completed

NCT Number: NCT01395693

Performance of the Salt Lake Mask System

Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ResMed Ltd

Sydney, New South Wales, 2153, Australia

About this study

Sleep-disordered breathing (SDB) is a significant direct cause of morbidity and mortality, as well as being a significant indirect cause of morbidity and mortality impacting greatly upon health and quality of life when left untreated. Positive Airway Pressure (PAP) therapy is an effective and proven form of medical treatment for many types of SDB.

In order for PAP therapy to be effective, patient interfaces(masks) need to be both effective in their delivery of this treatment and accepted by prospective and current patients for use. This study will investigate the ability of the Salt Lake mask system to act effectively as a patient interface in PAP therapy, and its ability to be accepted by patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients willing to give written informed consent
  • Patients who can read and comprehend English
  • Patients using the Swift FX mask system
  • Patients who can trial the mask for 7 nights
  • Patients who have used PAP therapy for a minimum of 6 months.

Exclusion criteria

  • Patients not willing to give written informed consent
  • Patients who can not read and comprehend English
  • Patients using an inappropriate mask system
  • Patients using Bilevel flow generators
  • Patients who are pregnant
  • Patients who are unable to comply with the protocol
  • Patients who have used PAP therapy for less than 6 months.

Treatment and study plan

Salt Lake mask system

Device

Study participants will Salt Lake mask system for 1 week in place of their current mask system.

Other names: Salt Lake

Primary outcomes

  1. Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.

    Time frame: 1 week

    Participants in the study will complete a subjective assessment of the levels of seal, comfort, stability and overall Performance of Salt Lake Mask System in use.

Secondary outcomes

  1. Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly

    Time frame: 1 week

    Participants in the study will subjectively assess the ease and intuitiveness of specific common assembly/diosassembly tasks related to the Salt Lake mask system.

  2. Subjectively Assessed Levels of Skin Markings

    Time frame: 1 week

    Participants in the study will subjectively assess the levels of Skin Markings experienced as a direct result of use of the Salt Lake mask system.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Assessment of the Performance of the Salt Lake Mask System as a Patient Interface in the Provision of Positive Airway Pressure (PAP) Therapy

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2011
Registry last updated
Apr 20, 2012

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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