Comparison of Auto-Adjusting Positive Airway Pressure Devices
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
APAP A (ResMed AirSense AutoSet)
APAP B (Apex iCH Auto)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Males aged ≥ 18 years
- Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
- Naive to CPAP therapy
- Participants willing and able to give written informed consent
Exclusion Criteria:
- Participants requiring Bi-level PAP
- Participants requiring supplemental oxygen
- Participants who are pregnant
- Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
Sites / Locations
- Center of Sleep Medicine, Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.
Outcomes
Primary Outcome Measures
Mean Apnoea-Hypopnoea-Index (AHI)
AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).
Mean Oxygen Desaturation Index (ODI)
Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour
Secondary Outcome Measures
Obstructive Apnoea Index (OAI)
Number of obstructive apnoeas per hour of nights sleep, Events/hour
Central Apnoea Index (CAI)
Number of central apnoeas during hours of sleep, events/hour
Mixed Apnoea Index (MAI)
Number of obstructive and central apnoeas per hours of nights sleep, Events/hour
Hypopnoea-Index HI
Number of Hypopnoeas per hour of nights sleep, Events/hour
Respiratory Effort Related Arousals RERAs
Number of RERAs per hour of nights sleep, Events/hour
Flow Limitation (%)
Percent of flow-limited breaths in relation to the overall breaths at night.
Mean O2 Saturation
Mean blood oxygen Saturation, %
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02357706
Brief Title
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Official Title
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.
Intervention Type
Device
Intervention Name(s)
APAP A (ResMed AirSense AutoSet)
Other Intervention Name(s)
Auto-Adjusting Positive Airway Pressure Device A
Intervention Description
Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
Intervention Type
Device
Intervention Name(s)
APAP B (Apex iCH Auto)
Other Intervention Name(s)
Auto-Adjusting Positive Airway Pressure Device B
Intervention Description
Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
Primary Outcome Measure Information:
Title
Mean Apnoea-Hypopnoea-Index (AHI)
Description
AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).
Time Frame
1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)
Title
Mean Oxygen Desaturation Index (ODI)
Description
Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour
Time Frame
1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.
Secondary Outcome Measure Information:
Title
Obstructive Apnoea Index (OAI)
Description
Number of obstructive apnoeas per hour of nights sleep, Events/hour
Time Frame
1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Title
Central Apnoea Index (CAI)
Description
Number of central apnoeas during hours of sleep, events/hour
Time Frame
1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Title
Mixed Apnoea Index (MAI)
Description
Number of obstructive and central apnoeas per hours of nights sleep, Events/hour
Time Frame
1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Title
Hypopnoea-Index HI
Description
Number of Hypopnoeas per hour of nights sleep, Events/hour
Time Frame
1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Title
Respiratory Effort Related Arousals RERAs
Description
Number of RERAs per hour of nights sleep, Events/hour
Time Frame
1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Title
Flow Limitation (%)
Description
Percent of flow-limited breaths in relation to the overall breaths at night.
Time Frame
1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Title
Mean O2 Saturation
Description
Mean blood oxygen Saturation, %
Time Frame
1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males aged ≥ 18 years
Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
Naive to CPAP therapy
Participants willing and able to give written informed consent
Exclusion Criteria:
Participants requiring Bi-level PAP
Participants requiring supplemental oxygen
Participants who are pregnant
Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingo Fietz, Prof
Organizational Affiliation
Charite Center of Sleep Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Sleep Medicine, Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparison of Auto-Adjusting Positive Airway Pressure Devices
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