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/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
Not applicable
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
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
Trial website
https://clinicaltrials.gov/study/NCT00906958
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00906958