Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02368639




Registration number
NCT02368639
Ethics application status
Date submitted
8/02/2015
Date registered
23/02/2015
Date last updated
11/08/2017

Titles & IDs
Public title
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
Scientific title
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
Secondary ID [1] 0 0
CIA-156
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Obesity Hypoventilation Syndrome 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Fisher & Paykel Healthcare PAP Device

Experimental: Positive airway pressure (PAP) device - Fisher & Paykel Healthcare PAP Device. Participants will sleep overnight using themodified positive airway pressure device. Their pressures will be titrated by a qualified sleep technician, they will then be optimised during the night.


Treatment: Devices: Fisher & Paykel Healthcare PAP Device
The device is a modified version of the Fisher & Paykel Icon continuous positive airway pressure (CPAP) device, which is a fully released product in New Zealand.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea hypopnea index (AHI)
Timepoint [1] 0 0
8 hours
Primary outcome [2] 0 0
Peripheral blood oxygen level (SpO2)
Timepoint [2] 0 0
8 hours

Eligibility
Key inclusion criteria
- Aged 18+

- Patients diagnosed with obesity hypoventilation syndrome (OHS) and/or obstructive
sleep apnea (OSA) by a practicing sleep or respiratory physician, requiring positive
airway pressure (PAP) therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recent cardiac or respiratory arrest

- Gastro intestinal bleeding, ileus or recent gastrointestinal surgery

- Coma, decreased level of consciousness or agitation

- Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma,
vomiting upper airway obstruction

- Cerebrospinal fluid leak, abnormalities of the cribiform plate or prior history of
head trauma.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
14
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 study will use a modified version of a positive airway pressure device to supply air to
the participant, while undergoing supervised polysomnography. Positive airway pressures are
typically applied to many patients with hypoventilation, in this study these pressures will
be titrated by a qualified sleep technician. During the night these pressures will be altered
to optimise comfort.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02368639
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/ct2/show/NCT02368639