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 ]
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