Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 8 for:    19339721 [PUBMED-IDS]

A Pilot Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD (STOP-BBACK)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02446769
Recruitment Status : Terminated (Difficulty recruiting patient population.)
First Posted : May 18, 2015
Results First Posted : July 10, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Philips Respironics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breathing-Related Sleep Disorder
Intervention Device: AVAPS-AE Non-invasive ventilation therapy
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Screening Period Standard of Care Experimental: AVAPS-AE Non-invasive Ventilation Therapy
Hide Arm/Group Description All participants that signed the consent. Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate.
Period Title: Screening Period
Started 18 0 0
Completed 7 0 0
Not Completed 11 0 0
Reason Not Completed
Screen Failure             11             0             0
Period Title: Study Period
Started 0 4 3
Completed 0 2 3
Not Completed 0 2 0
Reason Not Completed
Randomized in Error             0             2             0
Arm/Group Title All Participants
Hide Arm/Group Description All participants that were consented.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Due to the low enrollment, and low number of participants randomized into the study baseline analysis population description data was combined to provide more purposeful data.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  27.8%
>=65 years
13
  72.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
67.2  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
11
  61.1%
Male
7
  38.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
4
  22.2%
Not Hispanic or Latino
12
  66.7%
Unknown or Not Reported
2
  11.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
15
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
2
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants
39  (8.17)
Current Smokers  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
7
  38.9%
Gold Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Gold Stage II
4
  22.2%
Gold Stage III
4
  22.2%
Gold Stage IIII
1
   5.6%
Unknown
9
  50.0%
[1]
Measure Description:

GOLD is the Global Initiative for Chronic Obstructive Lung Disease stage or grade. Doctors assign grades based on four separate pieces of information:

How severe your current symptoms are, your spirometry results,the chances that your COPD will get worse, and the presence of other health problems. The higher the stage the more severe the COPD.

1.Primary Outcome
Title Composite End-point of Time to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).
Hide Description Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to (# of days) emergent and non-emergent healthcare utilization in patients with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD).
Time Frame 60 days post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected however data could not be analyzed because too few participants completed each arm to assess the amount of emergent healthcare utilization.
Arm/Group Title AVAPS-AE Non-invasive Ventilation Therapy Standard of Care Group
Hide Arm/Group Description:

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.

AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Evaluation and treatment of the participant’s sleep disordered breathing will be per their participant’s health care provider’s usual care pathway.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Healthcare Costs
Hide Description Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).
Time Frame 60 days post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected however data could not be analyzed because too few participants completed each arm to assess healthcare costs.
Arm/Group Title AVAPS-AE Non-invasive Ventilation Therapy Standard of Care Group
Hide Arm/Group Description:

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.

AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Evaluation and treatment of the participant’s sleep disordered breathing will be per their participant’s health care provider’s usual care pathway.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Quality of Life (SF-36) at 30 and 60 Days
Hide Description Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). The Short Form 36 (SF-36) is a set of quality of life measures. Scoring for this is a two step process, scores are converted to answers of zero to 100. Those scores are than averaged based upon category so that the lowest possible score is zero and highest possible score is 100. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame 30 and 60 days post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected however data could not be analyzed because too few participants completed each arm to assess the measure changes in the quality of life.
Arm/Group Title AVAPS-AE Non-invasive Ventilation Therapy Standard of Care Group
Hide Arm/Group Description:

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.

AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Evaluation and treatment of the participant’s sleep disordered breathing will be per their participant’s health care provider’s usual care pathway.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Quality of Life (FOSQ) at 30 and 60 Days
Hide Description

FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions).

Scores are provided on a 0 to 4 scale:

0- I don't do this activity for other reasons or missing response

1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was, calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired.

Time Frame 30 and 60 days post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected however data could not be analyzed because too few participants completed each arm to assess the change in quality of life.
Arm/Group Title AVAPS-AE Non-invasive Ventilation Therapy Standard of Care Group
Hide Arm/Group Description:

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.

AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Evaluation and treatment of the participant’s sleep disordered breathing will be per their participant’s health care provider’s usual care pathway.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Composite End-point of Time to Occurrence of Non-emergent Healthcare Utilization (Such as Scheduled Hospitalization, Scheduled Physician Office, Urgent Care Visits or Emergency Room Visits).
Hide Description Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).
Time Frame 60 days post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected however data could not be analyzed because too few participants completed each arm to assess non-emergent healthcare utilization.
Arm/Group Title AVAPS-AE Non-invasive Ventilation Therapy Standard of Care Group
Hide Arm/Group Description:

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.

AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Evaluation and treatment of the participant’s sleep disordered breathing will be per their participant’s health care provider’s usual care pathway.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Re-hospitalization Alone
Hide Description Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).
Time Frame 60 days post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected however data could not be analyzed because too few participants completed each arm to assess the average time to re-hospitalization.
Arm/Group Title AVAPS-AE Non-invasive Ventilation Therapy Standard of Care Group
Hide Arm/Group Description:

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.

AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Evaluation and treatment of the participant’s sleep disordered breathing will be per their participant’s health care provider’s usual care pathway.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry)
Hide Description Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data could not be analyzed because no participants enrolled in the registry.
Arm/Group Title AVAPS-AE Non-invasive Ventilation Therapy Standard of Care Group
Hide Arm/Group Description:

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.

AVAPS-AE Non-invasive ventilation therapy: Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Evaluation and treatment of the participant’s sleep disordered breathing will be per their participant’s health care provider’s usual care pathway.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 60 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Screening Period Standard of Care Experimental: AVAPS-AE Non-invasive Ventilation Therapy
Hide Arm/Group Description All participants that signed the consent. Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate.
All-Cause Mortality
Screening Period Standard of Care Experimental: AVAPS-AE Non-invasive Ventilation Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/4 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Screening Period Standard of Care Experimental: AVAPS-AE Non-invasive Ventilation Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/4 (0.00%)      1/3 (33.33%)    
Cardiac disorders       
Hyperkalemia *  0/18 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2
Cardiac Arrhythmia *  0/18 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
General disorders       
Fall secondary loss of consciousness *  0/18 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Renal and urinary disorders       
Acute Kidney Infection *  0/18 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Screening Period Standard of Care Experimental: AVAPS-AE Non-invasive Ventilation Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/4 (0.00%)      0/3 (0.00%)    
Enrollment was terminated early due to a high number of screen failures therefore data analysis with any statistical significance could not be performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chuck Cain
Organization: Philips
Phone: 412-542-3605
EMail: chuck.cain@philips.com
Layout table for additonal information
Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT02446769     History of Changes
Other Study ID Numbers: HRC-1426-BBACK-MS
First Submitted: April 9, 2015
First Posted: May 18, 2015
Results First Submitted: May 17, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 24, 2019