Congestive Heart Failure, Sleep Apnea Syndromes
Conditions
Brief summary
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.
Interventions
BEHAVIORALAirCare App
Tablet software to encourage adherence and support
Sponsors
AirCare Labs, LLC
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Congestive heart failure and sleep apnea
Exclusion criteria
* Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Adhering to Positive Airway Pressure (PAP) | one month | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention: AirCare System Study participants will receive a tablet computer with the AirCare system.
AirCare App: Tablet software to encourage adherence and support | 74 |
| Control: Standard of Care Standard care: This is the care that would be routinely provided by their healthcare provider | 72 |
| Total | 146 |
Baseline characteristics
| Characteristic | Control: Standard of Care | Total | Intervention: AirCare System |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 12.7 | 58.7 years STANDARD_DEVIATION 12.3 | 58.1 years STANDARD_DEVIATION 11.9 |
| Apnea Hypopnea Index (AHI, events/hr) | 27.2 events/hr STANDARD_DEVIATION 24 | 29.1 events/hr STANDARD_DEVIATION 24.4 | 31.0 events/hr STANDARD_DEVIATION 25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 16 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 49 Participants | 19 Participants |
| Race (NIH/OMB) White | 33 Participants | 76 Participants | 43 Participants |
| Sex: Female, Male Female | 26 Participants | 57 Participants | 31 Participants |
| Sex: Female, Male Male | 46 Participants | 89 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 74 | 4 / 72 |
| other Total, other adverse events | 1 / 74 | 4 / 72 |
| serious Total, serious adverse events | 17 / 74 | 17 / 72 |
Outcome results
Primary
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
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention: AirCare System | Number of Participants Adhering to Positive Airway Pressure (PAP) | 5 Participants |
| Control: Standard Care | Number of Participants Adhering to Positive Airway Pressure (PAP) | 3 Participants |
p-value: 0.72Chi-squared