Clinical Trial: Simplus and Eson Evaluation in Obesity Hypoventilation Syndrome (NZ)

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Simplus and Eson Evaluation in Obesity Hypoventilation Syndrome (NZ)

Brief Summary: This investigation is to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.

Detailed Summary: Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) for an overnight polysomnography.
Sponsor: Fisher and Paykel Healthcare

Current Primary Outcome: Objective Leak data [ Time Frame: 1 night ]

Obtained from the participant's device and polysomnography (PSG)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subjective measurement of Leak [ Time Frame: 1 night ]
    Questionnaire
  • Comfort [ Time Frame: 1 night ]
    Questionnaire
  • Ease of use [ Time Frame: 1 night ]
    Questionnaire
  • Sleep efficiency [ Time Frame: 1 night ]
    Obtained through the PSG
  • Wake after Sleep Onset (WASO) [ Time Frame: 1 night ]
    Obtained through the PSG
  • Arousal Index (AI) [ Time Frame: 1 night ]
    Obtained through the PSG


Original Secondary Outcome: Same as current

Information By: Fisher and Paykel Healthcare

Dates:
Date Received: June 25, 2015
Date Started: July 2015
Date Completion: December 2016
Last Updated: June 27, 2016
Last Verified: June 2016