Back to resultsModified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Primary Purpose
Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Nexus Flow Generator
VPAP Flow Generator 25
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
Eligibility Criteria
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
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
Sites / Locations
- Centre for Healthy Sleep
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nexus Flow Generator
VPAP Flow Generator 25
Arm Description
Participants were randomised to Nexus Flow Generator group for one night.
Participants were randomised to VPAP Flow Generator 25 group for one night.
Outcomes
Primary Outcome Measures
Apnoea-Hypopnoea Index (AHI)
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25
Oxygen Desaturation Index
Number of oxygen desaturations per hour of sleep
Secondary Outcome Measures
Comfort of Breathing
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
Satisfaction of Treatment
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
Refreshed Feel
Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00906958
Brief Title
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2009 (Actual)
Primary Completion Date
June 15, 2009 (Actual)
Study Completion Date
June 15, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nexus Flow Generator
Arm Type
Experimental
Arm Description
Participants were randomised to Nexus Flow Generator group for one night.
Arm Title
VPAP Flow Generator 25
Arm Type
Active Comparator
Arm Description
Participants were randomised to VPAP Flow Generator 25 group for one night.
Intervention Type
Device
Intervention Name(s)
Nexus Flow Generator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
VPAP Flow Generator 25
Intervention Description
Exiting VPAP Auto 25 Flow Generator with A10 Algorithm
Primary Outcome Measure Information:
Title
Apnoea-Hypopnoea Index (AHI)
Description
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25
Time Frame
One Night On Each Arm, approximately 8 hours each night
Title
Oxygen Desaturation Index
Description
Number of oxygen desaturations per hour of sleep
Time Frame
One Night On Each Arm, approximately 8 hours each night
Secondary Outcome Measure Information:
Title
Comfort of Breathing
Description
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
Time Frame
One Night On Each Arm, approximately 8 hours each night
Title
Satisfaction of Treatment
Description
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
Time Frame
One Night On Each Arm, approximately 8 hours each night
Title
Refreshed Feel
Description
Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?
Time Frame
One Night On Each Arm, approximately 8 hours each night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, PhD
Organizational Affiliation
ResMed/The University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Healthy Sleep
City
Bella Vista
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
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