Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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.
Query!
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
Query!
Secondary ID [1]
0
0
08177-0608
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Sleep apnoea
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Apnoea-Hypopnoea Index (AHI)
Query!
Assessment method [1]
0
0
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \& VPAP Auto 25
Query!
Timepoint [1]
0
0
One Night On Each Arm, approximately 8 hours each night
Query!
Primary outcome [2]
0
0
Oxygen Desaturation Index
Query!
Assessment method [2]
0
0
Number of oxygen desaturations per hour of sleep
Query!
Timepoint [2]
0
0
One Night On Each Arm, approximately 8 hours each night
Query!
Secondary outcome [1]
0
0
Comfort of Breathing
Query!
Assessment method [1]
0
0
Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale
Query!
Timepoint [1]
0
0
One Night On Each Arm, approximately 8 hours each night
Query!
Secondary outcome [2]
0
0
Satisfaction of Treatment
Query!
Assessment method [2]
0
0
Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale
Query!
Timepoint [2]
0
0
One Night On Each Arm, approximately 8 hours each night
Query!
Secondary outcome [3]
0
0
Refreshed Feel
Query!
Assessment method [3]
0
0
Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?
Query!
Timepoint [3]
0
0
One Night On Each Arm, approximately 8 hours each night
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/05/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/06/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
20
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Centre for Healthy Sleep - Bella Vista
Query!
Recruitment postcode(s) [1]
0
0
2135 - Bella Vista
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
ResMed
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00906958
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Klaus Schindhelm, PhD
Query!
Address
0
0
ResMed/The University of New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF