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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00906958




Registration number
NCT00906958
Ethics application status
Date submitted
13/05/2009
Date registered
21/05/2009
Date last updated
22/03/2021

Titles & IDs
Public title
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Scientific title
Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea
Secondary ID [1] 0 0
08177-0608
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 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 - Nexus Flow Generator
Treatment: Devices - VPAP Flow Generator 25

Experimental: Nexus Flow Generator - Participants were randomised to Nexus Flow Generator group for one night.

Active comparator: VPAP Flow Generator 25 - Participants were randomised to VPAP Flow Generator 25 group for one night.


Treatment: Devices: Nexus Flow Generator
The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Treatment: Devices: VPAP Flow Generator 25
Exiting VPAP Auto 25 Flow Generator with A10 Algorithm
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnoea-Hypopnoea Index (AHI)
Timepoint [1] 0 0
One Night On Each Arm, approximately 8 hours each night
Primary outcome [2] 0 0
Oxygen Desaturation Index
Timepoint [2] 0 0
One Night On Each Arm, approximately 8 hours each night
Secondary outcome [1] 0 0
Comfort of Breathing
Timepoint [1] 0 0
One Night On Each Arm, approximately 8 hours each night
Secondary outcome [2] 0 0
Satisfaction of Treatment
Timepoint [2] 0 0
One Night On Each Arm, approximately 8 hours each night
Secondary outcome [3] 0 0
Refreshed Feel
Timepoint [3] 0 0
One Night On Each Arm, approximately 8 hours each night

Eligibility
Key inclusion criteria
* Patients aged 18-80 years
* Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
* Patients who are using ResMed masks
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who are unable to provide written informed consent
* Patients who are unable to comprehend written and spoken English
* Patients who are using Bilevel PAP
* Patients who are pregnant
* Patients who are suffering any of the following:

* Acute respiratory infection
* Acute sinusitis, otitis media or perforated eardrum
* Pneumothorax or pneumomediastinum
* Recent history of severe epistaxis requiring medical attention

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
NA
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
11/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2009
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Centre for Healthy Sleep - Bella Vista
Recruitment postcode(s) [1] 0 0
2135 - Bella Vista

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, PhD
Address 0 0
ResMed/The University of New South Wales
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00906958