Congestive Heart FailureNCT02312765
Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
A study testing AirCare App in people with Congestive Heart Failure and Sleep Apnea Syndromes, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Sleep Apnea Syndromes
- What is being tested?
- AirCare App
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congestive heart failure and sleep apnea
Who cannot join
- Cognitive impairment
About this study
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.
- Conditions
- Congestive Heart Failure, Sleep Apnea Syndromes
- Being tested
- AirCare App
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirCare AppBehavioural
Tablet software to encourage adherence and support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Study participants will receive a tablet computer with the AirCare system. Receives: Behavioral: AirCare App |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- AirCare Labs, LLC
- Responsible party
- Principal investigator, Nalaka Gooneratne, University of Pennsylvania
- Investigators
- Nalaka Gooneratne, MD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312765
- Sponsor's protocol ID
- 820241
- Status last verified
- Jul 2020
- First submitted
- 1 Dec 2014
- Last updated
- 4 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
- ClinicalTrials.gov ID
- NCT02312765
- Acronym / sponsor ID
- 820241
- Conditions
- Congestive Heart Failure, Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- AirCare Labs, LLC
- Study start
- Nov 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Posted 4 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: AirCare AppStudy participants will receive a tablet computer with the AirCare system. |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Congestive heart failure and sleep apnea
Key exclusion criteria (1 listed)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirCare AppTablet software to encourage adherence and support | Behavioural | Intervention |
Primary outcome
Number of Participants Adhering to Positive Airway Pressure (PAP)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nalaka Gooneratne, MD study director
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing AirCare App in people with Congestive Heart Failure and Sleep Apnea Syndromes, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Adhering to Positive Airway Pressure (PAP) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.