NCT01395693

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1 month

First QC Date

June 29, 2011

Last Update Submit

April 19, 2012

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 week

Secondary Outcomes (2)

  • Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly

    1 week

  • Subjectively Assessed Levels of Skin Markings

    1 week

Study Arms (1)

Salt Lake mask system

EXPERIMENTAL
Device: Salt Lake mask system

Interventions

Salt Lake mask systemDEVICE

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

Also known as: Salt Lake
Salt Lake mask system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ResMed Ltd

Sydney, New South Wales, 2153, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Klaus Schindhelm

    ResMed

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 15, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

AU(1)