Trial Outcomes & Findings for 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 (NCT NCT02446769)

Last Updated: 2020-08-05

Results Overview

Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of participants with emergent and non-emergent healthcare utilization with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD), number of participants enrolled.

Recruitment status

TERMINATED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

60 days post-discharge

Results posted on

2020-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Screening Period All participants that signed the consent.	Standard of Care Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.	Experimental: AVAPS-AE Non-invasive Ventilation Therapy 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.
Screening Period STARTED	18	0	0
Screening Period COMPLETED	7	0	0
Screening Period NOT COMPLETED	11	0	0
Study Period STARTED	0	4	3
Study Period COMPLETED	0	2	3
Study Period NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Screening Period All participants that signed the consent.	Standard of Care Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.	Experimental: AVAPS-AE Non-invasive Ventilation Therapy 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.
Screening Period Screen Failure	11	0	0
Study Period Randomized in Error	0	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=18 Participants All participants that were consented.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	67.2 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Body Mass Index (BMI)	39 kg/m^2 STANDARD_DEVIATION 8.17 • n=5 Participants
Current Smokers	7 Participants n=5 Participants
Gold Stage Gold Stage II	4 Participants n=5 Participants
Gold Stage Gold Stage III	4 Participants n=5 Participants
Gold Stage Gold Stage IIII	1 Participants n=5 Participants
Gold Stage Unknown	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days post-discharge

Outcome measures

Outcome measures
Measure	AVAPS-AE Non-invasive Ventilation Therapy n=3 Participants 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.	Standard of Care Group n=2 Participants Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 60 days post-discharge

Population: Only one participant enrolled in the study required emergent healthcare utilization.

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).

Outcome measures

Outcome measures
Measure	AVAPS-AE Non-invasive Ventilation Therapy n=1 Participants 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.	Standard of Care Group Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
Composite End-point of Time (# of Days) to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).	21 days Standard Deviation 0	—

SECONDARY outcome

Timeframe: 60 days post-discharge

Population: Data was not collected as study was terminated.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 and 60 days post-discharge

Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on health-related quality of life. The Short Form 36 (SF-36) is a set of quality of life measures. Participants were asked at 30 days and 60 days in general what their overall health was. On a scale of 1 to 5 -1 being excellent, 5 being poor.

Outcome measures

Outcome measures
Measure	AVAPS-AE Non-invasive Ventilation Therapy n=3 Participants 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.	Standard of Care Group n=2 Participants Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
Change in Quality of Life (SF-36) at 30 and 60 Days 30 days	3.3 units on a scale Standard Deviation 1.41	4 units on a scale Standard Deviation 0
Change in Quality of Life (SF-36) at 30 and 60 Days 60 days	3.7 units on a scale Standard Deviation 3.5	3.5 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 30 and 60 days post-discharge

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.

Outcome measures

Outcome measures
Measure	AVAPS-AE Non-invasive Ventilation Therapy n=3 Participants 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.	Standard of Care Group n=2 Participants Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
Change in Quality of Life (FOSQ) at 30 and 60 Days 30 Days	15.1 units on a scale Standard Deviation 6.6	18.8 units on a scale Standard Deviation 0
Change in Quality of Life (FOSQ) at 30 and 60 Days 60 Days	15.5 units on a scale Standard Deviation 4.3	19.3 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	AVAPS-AE Non-invasive Ventilation Therapy n=3 Participants 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.	Standard of Care Group n=2 Participants Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
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).	0 days Standard Deviation 0	0 days Standard Deviation 0

SECONDARY outcome

Timeframe: 60 days post-discharge

Population: Only one enrolled participation was hospitalized.

Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to re-hospitalization alone.

Outcome measures

Outcome measures
Measure	AVAPS-AE Non-invasive Ventilation Therapy n=1 Participants 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.	Standard of Care Group Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.
Time to Re-hospitalization Alone	21 days Standard Deviation 0	—

SECONDARY outcome

Timeframe: 3 years

Population: No participants were enrolled in the registry.

Outcome measures

Outcome data not reported

Adverse Events

Screening Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental: AVAPS-AE Non-invasive Ventilation Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Screening Period n=18 participants at risk All participants that signed the consent.	Standard of Care n=4 participants at risk Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.	Experimental: AVAPS-AE Non-invasive Ventilation Therapy n=3 participants at risk 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.
Cardiac disorders Hyperkalemia	0.00% 0/18 • 60 days	0.00% 0/4 • 60 days	33.3% 1/3 • Number of events 2 • 60 days
Cardiac disorders Cardiac Arrhythmia	0.00% 0/18 • 60 days	0.00% 0/4 • 60 days	33.3% 1/3 • Number of events 1 • 60 days
Renal and urinary disorders Acute Kidney Infection	0.00% 0/18 • 60 days	0.00% 0/4 • 60 days	33.3% 1/3 • Number of events 1 • 60 days
General disorders Fall secondary loss of consciousness	0.00% 0/18 • 60 days	0.00% 0/4 • 60 days	33.3% 1/3 • Number of events 1 • 60 days

Other adverse events

Adverse event data not reported

Additional Information

Chuck Cain

Philips

Phone: 412-542-3605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place