An interventional study of AirCare App in Congestive Heart Failure and Sleep Apnea Syndromes, sponsored by University of Pennsylvania. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-04.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Supportive care
Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients with heart failure. Helping patients to effectively use the most common form of treatment for sleep apnea, positive airway pressure therapy, can improve their heart function. This can reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs has developed an innovative solution that allows patients to communicate with health care providers 24 hours a day, thus allowing them to get the help they need to effectively use positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 146 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study participants will receive a tablet computer with the AirCare system.
Behavioral: AirCare App
Standard care
Tablet software to encourage adherence and support
Number of Participants Adhering to Positive Airway Pressure (PAP)
PAP adherence will be measured from the PAP unit (which monitors nightly hours of use and records this data; this is the standard of care clinical practice approach used currently by health care providers to monitor PAP use) and will be reported as Number of Participants who Adhered to Positive Airway Pressure (PAP) Treatment (adherence defined as \>4 hours of use per night on average across the 30 day period). For example, if 5 subjects used PAP for more than 4 hours per night on average across the 30 day period, then the number of adherent participants is 5.
Time frame: one month
| Milestone | Intervention: AirCare System | Control: Standard of Care |
|---|---|---|
| Started | 74 | 72 |
| Completed | 19 | 36 |
| Not completed | 55 | 36 |
PAP adherence will be measured from the PAP unit (which monitors nightly hours of use and records this data; this is the standard of care clinical practice approach used currently by health care providers to monitor PAP use) and will be reported as Number of Participants who Adhered to Positive Airway Pressure (PAP) Treatment (adherence defined as \>4 hours of use per night on average across the 30 day period). For example, if 5 subjects used PAP for more than 4 hours per night on average across the 30 day period, then the number of adherent participants is 5.
| Participants | Intervention: AirCare System | Control: Standard Care |
|---|---|---|
| Number of Participants Adhering to Positive Airway Pressure (PAP) | 5 | 3 |
Collected over One month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention: AirCare System | 3/74 (4.1%) | 17/74 (23%) | 1/74 (1.4%) |
| Control: Standard Care | 4/72 (5.6%) | 17/72 (23.6%) | 4/72 (5.6%) |
| Event | Intervention: AirCare System | Control: Standard Care |
|---|---|---|
| CHFCardiac disorders | 13/74 | 10/72 |
| CADCardiac disorders | 4/74 | 1/72 |
| PVTCardiac disorders | 2/74 | 2/72 |
| Atrial FibrillationCardiac disorders | 1/74 | 1/72 |
| Cardiac ArrestCardiac disorders | 0/74 | 1/72 |
| HypotensionCardiac disorders | 0/74 | 1/72 |
| Pacemaker bleedingCardiac disorders | 0/74 | 1/72 |
| Pacemaker malfunctionCardiac disorders | 0/74 | 1/72 |
| GI BleedGastrointestinal disorders | 0/74 | 1/72 |
| SepsisInfections and infestations | 0/74 | 1/72 |
| Event | Intervention: AirCare System | Control: Standard Care |
|---|---|---|
| Urinary Tract InfectionInfections and infestations | 0/74 | 1/72 |
| DiarrheaGastrointestinal disorders | 0/74 | 1/72 |
| ToothacheGeneral disorders | 0/74 | 1/72 |
| Atrial FibrillationCardiac disorders | 0/74 | 1/72 |
| LightheadednessNervous system disorders | 1/74 | 0/72 |
Patients admitted with heart failure
| Age, Continuous(years) | Intervention: AirCare System | Control: Standard of Care | Total |
|---|---|---|---|
| Mean | 58.1 ± 11.9 | 59.4 ± 12.7 | 58.7 ± 12.3 |
| Sex: Female, Male(Participants) | Intervention: AirCare System | Control: Standard of Care | Total |
|---|---|---|---|
| Female | 31 | 26 | 57 |
| Male | 43 | 46 | 89 |
| Race (NIH/OMB)(Participants) | Intervention: AirCare System | Control: Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 8 | 16 |
| White | 43 | 33 | 76 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 19 | 30 | 49 |
| Apnea Hypopnea Index (AHI, events/hr)(events/hr) | Intervention: AirCare System | Control: Standard of Care | Total |
|---|---|---|---|
| Mean | 31.0 ± 25.0 | 27.2 ± 24 | 29.1 ± 24.4 |
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