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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/NCT01943708




Registration number
NCT01943708
Ethics application status
Date submitted
10/07/2011
Date registered
17/09/2013
Date last updated
8/08/2014

Titles & IDs
Public title
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
Scientific title
A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy
Secondary ID [1] 0 0
FPH-SA-10-07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

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

Active Comparator: Continuous positive airway pressure (CPAP) device. - Standard CPAP therapy

Experimental: Auto-CPAP device (SPAP). - Novel Auto-CPAP algorithm


Treatment: Devices: SPAP
Novel Auto-algorithm for Auto-CPAP device

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

Outcomes
Primary outcome [1] 0 0
AHI
Timepoint [1] 0 0
one post study night (once PSG is scored)

Eligibility
Key inclusion criteria
- Aged =18 years with mild-to-severe OSA (Apnea Hypopnea Index equal to or greater than
5 per hour).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any medical condition which contraindicates (see Appendix A) the use of CPAP or
AutoCPAP.

- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).

- Unstable psychiatric disease.

- Other significant sleep disorder.

- Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined
by the investigation investigator.

- Any known factor or disease that might interfere with treatment compliance,
investigation conduct or interpretation of the results such as psychiatric disease,
history of non compliance to medical regimens, or unwillingness to comply with
investigational requirements.

- Participation in another clinical trial in the previous month.

- Less than 2 hours recorded sleep in either arm

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
74
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 single-blind randomised crossover trial aims to compare the efficacy of a novel
Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an
OSA population, aged over 18.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01943708
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/NCT01943708