Sleep Apnea, ObstructiveNCT03056443
Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients
A study testing Continuous Positive Airway Pressure (CPAP) in people with Sleep Apnea, Obstructive and Heart Failure, run by West Virginia University at 1 site in United States.
Trial summary
The study aimed to examine the effect of Continuous Positive Airway Pressure (CPAP) initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure patients on reducing 30-day hospital readmission rate through a clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Heart Failure
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2016to 31 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
- Hospitalized having a documented history of heart failure
- Anticipated hospitalization of more than 24 hours
- Subject has obtained a score of > 15 on the Ohio Sleep Medicine Institute Preoperative questionnaire.
- Subject has an apnea-hypopneas index (AHI) of > 5/h as confirmed by sleep medicine physician
Who cannot join
- The presence of any conditions that the investigator feels will interfere with the use of CPAP
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients: A Randomized Clinical Trial
The study aimed to examine the effect of Continuous Positive Airway Pressure (CPAP) initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure patients on reducing 30-day hospital readmission rate through a clinical trial.
Read the detailed description
Following consent adult patients hospitalized with a medical history of heart failure and meeting study eligibility criteria will be screened for obstructive sleep apnea using the Ohio Sleep Medicine Institute Preoperative Questionnaire.
If the probability of sleep apnea is high (Sleep apnea clinical Score >15) then participants will complete the Epworth Daytime Sleepiness scale and the Minnesota Living with HeartFailure questionnaire. The patient will then be evaluated by the sleep medicine team with a portable polysomnography monitor which has been shown to be equivalent to standard in-laboratory polysomnography. All participants with apnea-hypopnea index (AHI) ≥ 5events/h in whom sleep disordered breathing is confirmed by sleep medicine physician will be eligible for randomization.
Participants will be randomized into an auto-adjusting Continuous Positive Airway Pressure (CPAP) group or standard of care (control) group.
CPAP Arm (Intervention): CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
Standard of Care Arm (Comparator): CPAP initiation per standard of care based on approval by insurance company and DME company with management as per usual standards of clinical care for heart failure. This group will be scheduled for follow-up with a phone call at 2- 3 weeks post discharge and then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress.
- Conditions
- Sleep Apnea, Obstructive, Heart Failure
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Medical subject headings
- Sleep Apnea, Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure-CPAP | Experimental | CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
| Standard of Care | No intervention | CPAP initiation per standard of care based on approval by insurance company and DME company with management as per usual standards of clinical care for heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Hospital Readmission Within 30 Days of Hospital Discharge.
Thirty-day hospital readmission will be defined as a hospitalization or visit to the emergency department (ED) for a cardiac cause > 48 h after discharge. A readmission will be defined as a hospitalization for any reason within 30 days after discharge, and only the first readmission will be counted in case of multiple readmission in the 30-day period.
Measured: From hospital discharge to any hospitalization readmission within 30 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start8 Feb 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Stansbury, MD, West Virginia University
- Investigators
- Robert Stansbury, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056443
- Sponsor's protocol ID
- WVU02HSC16
- Status last verified
- Jan 2022
- First submitted
- 13 Feb 2017
- Last updated
- 16 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stansbury R, Abdelfattah M, Chan J, Mittal A, Alqahtani F, Sharma S. Hospital screening for obstructive sleep apnea in patients admitted to a rural, tertiary care academic hospital with heart failure. Hosp Pract (1995). 2020 Dec;48(5):266-271. doi: 10.1080/21548331.2020.1799601. Epub 2020 Aug 4.
PubMed 32715796
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03056443
- Acronym / sponsor ID
- WVU02HSC16
- Conditions
- Sleep Apnea, Obstructive, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Posted 16 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to examine the effect of Continuous Positive Airway Pressure (CPAP) initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure patients on reducing 30-day hospital readmission rate through a clinical trial.
Detailed description
Following consent adult patients hospitalized with a medical history of heart failure and meeting study eligibility criteria will be screened for obstructive sleep apnea using the Ohio Sleep Medicine Institute Preoperative Questionnaire.
If the probability of sleep apnea is high (Sleep apnea clinical Score >15) then participants will complete the Epworth Daytime Sleepiness scale and the Minnesota Living with HeartFailure questionnaire. The patient will then be evaluated by the sleep medicine team with a portable polysomnography monitor which has been shown to be equivalent to standard in-laboratory polysomnography. All participants with apnea-hypopnea index (AHI) ≥ 5events/h in whom sleep disordered breathing is confirmed by sleep medicine physician will be eligible for randomization.
Participants will be randomized into an auto-adjusting Continuous Positive Airway Pressure (CPAP) group or standard of care (control) group.
CPAP Arm (Intervention): CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
Standard of Care Arm (Comparator): CPAP initiation per standard of care based on approval by insurance company and DME company with management as per usual standards of clinical care for heart failure. This group will be scheduled for follow-up with a phone call at 2- 3 weeks post discharge and then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure-CPAP | Experimental | Device: Continuous Positive Airway Pressure (CPAP)CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. |
| Standard of Care | No intervention | –CPAP initiation per standard of care based on approval by insurance company and DME company with management as per usual standards of clinical care for heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized having a documented history of heart failure
- Anticipated hospitalization of more than 24 hours
- Subject has obtained a score of > 15 on the Ohio Sleep Medicine Institute Preoperative questionnaire.
- Subject has an apnea-hypopneas index (AHI) of > 5/h as confirmed by sleep medicine physician
Key exclusion criteria (1 listed)
- The presence of any conditions that the investigator feels will interfere with the use of CPAP
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP. | Device | Continuous Positive Airway Pressure-CPAP |
Primary outcome
All-cause Hospital Readmission Within 30 Days of Hospital Discharge.
Time frame: From hospital discharge to any hospitalization readmission within 30 days from discharge
Thirty-day hospital readmission will be defined as a hospitalization or visit to the emergency department (ED) for a cardiac cause > 48 h after discharge. A readmission will be defined as a hospitalization for any reason within 30 days after discharge, and only the first readmission will be counted in case of multiple readmission in the 30-day period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32715796Stansbury R, Abdelfattah M, Chan J, Mittal A, Alqahtani F, Sharma S. Hospital screening for obstructive sleep apnea in patients admitted to a rural, tertiary care academic hospital with heart failure. Hosp Pract (1995). 2020 Dec;48(5):266-271. doi: 10.1080/21548331.2020.1799601. Epub 2020 Aug 4.
- Individual participant dataSharing planned: No
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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.
Robert Stansbury, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) in people with Sleep Apnea, Obstructive and Heart Failure, run by West Virginia University at 1 site in United States.
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 4 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 16 Feb 2022). 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?
All-cause Hospital Readmission Within 30 Days of Hospital Discharge. (time frame: From hospital discharge to any hospitalization readmission within 30 days from discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03056443, which also lists 1 linked publication.
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 16 Feb 2022.