Breathing-Related Sleep Disorder
Conditions
Brief summary
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD. Hospitalized patients with comorbid COPD who are at high risk for readmission will be recruited. Specifically patients with comorbid COPD who are to be discharged with (a) admission diagnosis of COPD (GOLD stage II or greater); AND (b) either a prior non-elective hospitalization (one in the past 12 months) OR active smoker. Such participants will undergo questionnaire-based screening for sleep-disordered breathing (STOP-BANG questionnaire) and if they have a high risk for Sleep Disordered Breathing (SDB) (\> 3 points) will undergo an overnight portable sleep study for screening prior to hospital discharge (AHI \> 10 per hour; \>3% oxygen desaturation for hypopneas). After randomization and prior to discharge, participants will either be initiated on AVAPS-AE therapy (intervention arm) for 60 days or will be referred to the sleep center for further diagnostic testing and therapy initiation (standard of care arm). Participants will complete quality of life questionnaires Functional outcomes of sleep questionnaire (FOSQ) at baseline (in-person), and in 30 and 60 days (by mail) post discharge. Information regarding hospital admission, diagnostic tests, medication changes, and procedures will be collected from all participants. Discharge summaries of re-hospitalizations and office or ER visits, as well as diagnostics tests and therapies received will be collected for measuring healthcare costs. Participants will have an option to enroll in a registry for a 3 year follow-up and will also be queried on a yearly basis regarding hospitalizations, cardiovascular events, and assessment of vital statistics in the National Death Index registry. The study will conclude when all randomized participants have been followed for a minimum of 60 days.
Interventions
DEVICEAVAPS-AE Non-invasive ventilation therapy
Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.
Sponsors
University of Arizona
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized patients who are at high risk for readmission who are at least 18 years of age. 2. Specifically patients with (a) admission diagnosis of COPD AND (b) either a prior non-elective hospitalization (One in the past 12 months) OR active smoker who are ready for discharge AND (c) are also found to have sleep-disordered breathing (AHI ≥ 10 per hour; \>3% oxygen desaturation for hypopneas) by overnight portable respiratory study prior to hospital discharge. 3. Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 \<70% predicted post BD). 4. No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year
Exclusion criteria
1. Central sleep apnea (Central apnea index \>5 per hour; and/or \>50% are central apneas & hypopneas) 2. Clinically unstable, i.e., Acute Respiratory Failure, hypotensive shock, uncontrolled cardiac ischemia or arrhythmias, requiring life support ventilation or as otherwise determined by the investigator 3. Participants with Stage III & IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification 4. Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator. 5. Lack of medical insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). | 60 days post-discharge | 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. |
| 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). | 60 days post-discharge | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (FOSQ) at 30 and 60 Days | 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. |
| 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). | 6 months | 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). |
| Healthcare Costs | 60 days post-discharge | 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). |
| Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry) | 3 years | 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 to Re-hospitalization Alone | 60 days post-discharge | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to re-hospitalization alone. |
| Change in Quality of Life (SF-36) at 30 and 60 Days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants that were consented. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Screening Period | Screen Failure | 11 | 0 | 0 |
| Study Period | Randomized in Error | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 67.2 years STANDARD_DEVIATION 7 |
| Body Mass Index (BMI) | 39 kg/m^2 STANDARD_DEVIATION 8.17 |
| Current Smokers | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Gold Stage Gold Stage II | 4 Participants |
| Gold Stage Gold Stage III | 4 Participants |
| Gold Stage Gold Stage IIII | 1 Participants |
| Gold Stage Unknown | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 18 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 18 | 0 / 4 | 1 / 3 |
Outcome results
Primary
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).
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
Population: Only one participant enrolled in the study required emergent healthcare utilization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AVAPS-AE Non-invasive Ventilation Therapy | 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 |
Primary
Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).
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.
Time frame: 60 days post-discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AVAPS-AE Non-invasive Ventilation Therapy | Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). | 1 Participants |
| Standard of Care Group | Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). | 0 Participants |
Secondary
Change in Quality of Life (FOSQ) at 30 and 60 Days
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AVAPS-AE Non-invasive Ventilation Therapy | Change in Quality of Life (FOSQ) at 30 and 60 Days | 60 Days | 15.5 units on a scale | Standard Deviation 4.3 |
| AVAPS-AE Non-invasive Ventilation Therapy | Change in Quality of Life (FOSQ) at 30 and 60 Days | 30 Days | 15.1 units on a scale | Standard Deviation 6.6 |
| Standard of Care Group | Change in Quality of Life (FOSQ) at 30 and 60 Days | 30 Days | 18.8 units on a scale | Standard Deviation 0 |
| Standard of Care Group | Change in Quality of Life (FOSQ) at 30 and 60 Days | 60 Days | 19.3 units on a scale | Standard Deviation 0.5 |
Secondary
Change in Quality of Life (SF-36) at 30 and 60 Days
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.
Time frame: 30 and 60 days post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AVAPS-AE Non-invasive Ventilation Therapy | Change in Quality of Life (SF-36) at 30 and 60 Days | 30 days | 3.3 units on a scale | Standard Deviation 1.41 |
| AVAPS-AE Non-invasive Ventilation Therapy | Change in Quality of Life (SF-36) at 30 and 60 Days | 60 days | 3.7 units on a scale | Standard Deviation 3.5 |
| Standard of Care Group | Change in Quality of Life (SF-36) at 30 and 60 Days | 60 days | 3.5 units on a scale | Standard Deviation 0.7 |
| Standard of Care Group | Change in Quality of Life (SF-36) at 30 and 60 Days | 30 days | 4 units on a scale | Standard Deviation 0 |
Secondary
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).
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: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AVAPS-AE Non-invasive Ventilation Therapy | 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 |
| Standard of Care Group | 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 |
Secondary
Healthcare Costs
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
Population: Data was not collected as study was terminated.
Secondary
Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry)
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
Population: No participants were enrolled in the registry.
Secondary
Time to Re-hospitalization Alone
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to re-hospitalization alone.
Time frame: 60 days post-discharge
Population: Only one enrolled participation was hospitalized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AVAPS-AE Non-invasive Ventilation Therapy | Time to Re-hospitalization Alone | 21 days | Standard Deviation 0 |