The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02486380




Registration number
NCT02486380
Ethics application status
Date submitted
25/06/2015
Date registered
1/07/2015
Date last updated
18/04/2018

Titles & IDs
Public title
Simplus and Eson Evaluation in Obesity Hypoventilation Syndrome (NZ)
Scientific title
Simplus and Eson Evaluation in Obesity Hypoventilation Syndrome (NZ)
Secondary ID [1] 0 0
CIA-162
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity Hypoventilation Syndrome 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Simplus/Eson

Experimental: Full face/Nasal masks - Simplus/Eson


Treatment: Devices: Simplus/Eson
Released product Simplus and Eson masks

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Leak data - Obtained from the participant's device and polysomnography (PSG)
Timepoint [1] 0 0
1 night
Secondary outcome [1] 0 0
Subjective measurement of Leak - Questionnaire
Timepoint [1] 0 0
1 night
Secondary outcome [2] 0 0
Comfort - Questionnaire
Timepoint [2] 0 0
1 night
Secondary outcome [3] 0 0
Ease of use - Questionnaire
Timepoint [3] 0 0
1 night
Secondary outcome [4] 0 0
Sleep efficiency - Obtained through the PSG
Timepoint [4] 0 0
1 night
Secondary outcome [5] 0 0
Wake after Sleep Onset (WASO) - Obtained through the PSG
Timepoint [5] 0 0
1 night
Secondary outcome [6] 0 0
Arousal Index (AI) - Obtained through the PSG
Timepoint [6] 0 0
1 night

Eligibility
Key inclusion criteria
- Aged 18+

- Diagnosed with OHS by a practicing physician

- Existing full face mask user or a nasal mask user

- Prescribed PAP therapy (Bi-Level or CPAP)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to give informed consent

- Pregnant or think they may be pregnant

- Anatomical or physiological conditions making PAP therapy inappropriate

- Patients requiring supplemental oxygen with their PAP device

- Patients who are in a coma or decreased level of consciousness

- Existing Simplus and Eson users

- No arterial PCO2 value from their medical records

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02486380
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bhavi Ogra, BSc
Address 0 0
Fisher & Paykel Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02486380