Obstructive Sleep ApneaNCT01997866
Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure
A study testing STOP-BANG Scoring Model and Polysomnogram Sleep Study in people with Obstructive Sleep Apnea and Sleep Apnea, run by University of Florida at 1 site in United States.
Trial summary
Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the STOP-BANG Scoring Model. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure
- What is being tested?
- STOP-BANG Scoring Model and Polysomnogram Sleep Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has:
- CHF (systolic, diastolic, any etiology), or
- Normal Ejection Fraction (EF) and most recent:
- Age less than 50: N-Terminal Pro Brain Natriuretic Peptide (NTPBNP) > 400,
- Age 50 and older: NTPBNP > 750,
- If no NTPBNP done: then Brain Natriuretic Peptide (BNP) > 200 (some newly referred patients will only have this available at their first visit, or
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- Normal EF, no BNP done, and CHF documented in History or Problem List
- Admitted to the Hospital Medicine service, General Medicine Teaching service, Medicine Cardiology Team (MCT) service, Heart Failure service, or Community Health and Family Medicine (CHFM) service, OR Patient of the Congestive Heart Failure Clinic
- Patient has had at least 2 encounters (hospital inpatient admission, hospital observation admission, or ED visit) with University of Florida (UF) Health during the 12-month period immediately prior to the current admission (not including the current admission).
- English Speaking
- Males \& Females
- Age 18 to 110
- Agreement to return to Gainesville for regular follow-up visits
Who cannot join
- Decisionally impaired, cognitively impaired, or demented patient who has a surrogate, proxy, or guardian
- Current Drug/Alcohol abuse as evidenced by a) positive urine toxicology screen for cocaine or amphetamines during current admission, b) positive blood alcohol level upon admission, or c) documentation by current providers of continued abuse of alcohol or drugs
- Previous diagnosis of sleep apnea and on current treatment
- Uncontrolled Ventricular Dysrhythmias; sustained episodes of ventricular tachycardia or ventricular fibrillation in the hospital
- Evidence of current ischemia evidenced by elevated Troponin unrelated to Chronic Kidney Disease, or < 6 weeks since Myocardial Infarction (MI)
- Palliative care or Life expectancy < 6 months
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- Isolated Cor Pulmonale - predominantly right ventricular dysfunction, Right Ventricular Systolic Pressure (RVSP) >50 and/or on the following medications for pulmonary hypertension: sildenafil (Viagra®), tadalafil (Adcirca®, Cialis®), IV or sub-cutaneous (SC) treprostinil (Remodulin®; Tyvaso™), ambrisentan (Letairis®), bosentan (Tracleer®), IV epoprostenol, inhaled iloprost (Ventavis®)
- On 5 liters or greater of O2
- Self-Pay Status
- Known Pregnancy
- Vulnerable Subjects such as prisoners, decisionally impaired/comatose individuals, terminally ill patients, UF/Shands/Veterans Administration (VA) staff, UF students
Trial locations and contacts
1 site in 1 country.
About this study
Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the STOP-BANG Scoring Model. (STOP-BANG stands for Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference, Gender.) Patients with high risk of Obstructive Sleep Apnea (OSA) will be referred for evaluation and treatment of Sleep Apnea. They will be followed to determine if treatment of Sleep Apnea improves their quality of life and decreases their utilization of the Hospital and Emergency Department (ED).
Read the detailed description
Patients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or visiting our outpatient Congestive Heart Failure clinic will be screened using the STOP-BANG Scoring Model. Patients with high risk of Obstructive Sleep Apnea will be referred to the Sleep Center physicians for evaluation and treatment. Patients will be followed for one year to determine if the treatment for Sleep Apnea improves their Quality of Life and decreases Hospital and Emergency Department utilization.
- Being tested
- STOP-BANG Scoring Model, Polysomnogram Sleep Study
- Keywords
- Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure, Heart Failure
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP-BANG Scoring ModelOther
Patients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or visiting our outpatient Congestive Heart Failure Clinic will be administered the STOP-BANG Scoring Model to determine whether they are considered high-risk or low-risk for Sleep Apnea.
Polysomnogram Sleep StudyOther
Patients determined by the STOP-BANG Scoring Model to be high-risk for Sleep Apnea will be referred to the Sleep Center physicians for evaluation and treatment. If medically indicated, a Polysomnogram Sleep Study will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Congestive Heart Failure | Other | STOP-BANG Scoring Model
Polysomnogram Sleep Study Receives: Other: STOP-BANG Scoring Model; Other: Polysomnogram Sleep Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hospital Admissions
Measured: Compare the number of Hospital Admissions during the 12-month period immediately prior to the index admission to the number of Hospital Admissions during the 12-month period immediately following the study intervention
Number of Hospitalized Days
Measured: Compare the number of Hospitalized Days during the 12-month period immediately prior to the index admission to the number of Hospitalized Days during the 12-month period immediately following the study intervention
Number of Emergency Department Visits
Measured: Compare the number of Emergency Department Visits during the 12-month period immediately prior to the index admission to the number of Emergency Department Visits during the 12-month period immediately following the study intervention
Secondary outcomes (12)
Epworth Sleepiness Scale
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Measured: Change from Baseline to 6 weeks
Epworth Sleepiness Scale
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Measured: Change from Baseline to 12 months
Functional Outcome of Sleep Quality
Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty
Measured: Change from Baseline to 3 months
Functional Outcome of Sleep Quality
Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty
Measured: Change from Baseline to 12 months
Residual Apnea Hypopnea Index
This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.
Measured: at 6 weeks
Epworth Sleepiness Scale
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Measured: Change from Baseline to 3 months
Functional Outcome of Sleep Quality
Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty
Measured: Change from Baseline to 6 weeks
Residual Apnea Hypopnea Index
This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.
Measured: at 3 months
Residual Apnea Hypopnea Index
This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.
Measured: at 12 months
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Compliance for a given night would be 4 hours use or more.
Measured: at 6 weeks
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Compliance for a given night would be 4 hours use or more.
Measured: at 3 months
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Compliance for a given night would be 4 hours use or more.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJan 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: Re-evaluate inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Leverence, M.D., Principal investigator, University of FloridaNila Radhakrishnan, M.D., Study chair, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997866
- Sponsor's protocol ID
- 201300300
- Status last verified
- May 2017
- First submitted
- 1 Nov 2013
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01997866
- Acronym / sponsor ID
- 201300300
- Keywords
- Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure, Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Re-evaluate inclusion/exclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the STOP-BANG Scoring Model. (STOP-BANG stands for Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference, Gender.) Patients with high risk of Obstructive Sleep Apnea (OSA) will be referred for evaluation and treatment of Sleep Apnea. They will be followed to determine if treatment of Sleep Apnea improves their quality of life and decreases their utilization of the Hospital and Emergency Department (ED).
Detailed description
Patients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or visiting our outpatient Congestive Heart Failure clinic will be screened using the STOP-BANG Scoring Model. Patients with high risk of Obstructive Sleep Apnea will be referred to the Sleep Center physicians for evaluation and treatment. Patients will be followed for one year to determine if the treatment for Sleep Apnea improves their Quality of Life and decreases Hospital and Emergency Department utilization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Congestive Heart Failure | Other | Other: STOP-BANG Scoring Model, Other: Polysomnogram Sleep StudySTOP-BANG Scoring Model Polysomnogram Sleep Study |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient has:
- Admitted to the Hospital Medicine service, General Medicine Teaching service, Medicine Cardiology Team (MCT) service, Heart Failure service, or Community Health and Family Medicine (CHFM) service, OR Patient of the Congestive Heart Failure Clinic
- Patient has had at least 2 encounters (hospital inpatient admission, hospital observation admission, or ED visit) with University of Florida (UF) Health during the 12-month period immediately prior to the current admission (not including the current admission).
- English Speaking
- Males \& Females
Key exclusion criteria (11 listed)
- Decisionally impaired, cognitively impaired, or demented patient who has a surrogate, proxy, or guardian
- Current Drug/Alcohol abuse as evidenced by a) positive urine toxicology screen for cocaine or amphetamines during current admission, b) positive blood alcohol level upon admission, or c) documentation by current providers of continued abuse of alcohol or drugs
- Previous diagnosis of sleep apnea and on current treatment
- Uncontrolled Ventricular Dysrhythmias; sustained episodes of ventricular tachycardia or ventricular fibrillation in the hospital
- Evidence of current ischemia evidenced by elevated Troponin unrelated to Chronic Kidney Disease, or < 6 weeks since Myocardial Infarction (MI)
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 |
|---|---|---|
| STOP-BANG Scoring ModelPatients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or visiting our outpatient Congestive Heart Failure Clinic will be administered the STOP-BANG Scoring Model to determine whether they are considered high-risk or low-risk for Sleep Apnea. | Other | Patients with Congestive Heart Failure |
| Polysomnogram Sleep StudyPatients determined by the STOP-BANG Scoring Model to be high-risk for Sleep Apnea will be referred to the Sleep Center physicians for evaluation and treatment. If medically indicated, a Polysomnogram Sleep Study will be performed. | Other | Patients with Congestive Heart Failure |
Primary outcome
Number of Hospital Admissions
Time frame: Compare the number of Hospital Admissions during the 12-month period immediately prior to the index admission to the number of Hospital Admissions during the 12-month period immediately following the study intervention
Number of Hospitalized Days
Time frame: Compare the number of Hospitalized Days during the 12-month period immediately prior to the index admission to the number of Hospitalized Days during the 12-month period immediately following the study intervention
Number of Emergency Department Visits
Time frame: Compare the number of Emergency Department Visits during the 12-month period immediately prior to the index admission to the number of Emergency Department Visits during the 12-month period immediately following the study intervention
12 secondary outcomes
Epworth Sleepiness Scale
Time frame: Change from Baseline to 6 weeks
Epworth Sleepiness Scale
Time frame: Change from Baseline to 12 months
Functional Outcome of Sleep Quality
Time frame: Change from Baseline to 3 months
Functional Outcome of Sleep Quality
Time frame: Change from Baseline to 12 months
Residual Apnea Hypopnea Index
Time frame: at 6 weeks
Epworth Sleepiness Scale
Time frame: Change from Baseline to 3 months
Functional Outcome of Sleep Quality
Time frame: Change from Baseline to 6 weeks
Residual Apnea Hypopnea Index
Time frame: at 3 months
Residual Apnea Hypopnea Index
Time frame: at 12 months
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Time frame: at 6 weeks
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Time frame: at 3 months
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Time frame: at 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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 Leverence, M.D. principal investigator
University of Florida
Nila Radhakrishnan, M.D. study chair
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOP-BANG Scoring Model and Polysomnogram Sleep Study in people with Obstructive Sleep Apnea and Sleep Apnea, run by University of Florida 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 13 inclusion and 11 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: withdrawn, as of the sponsor's last update on 17 May 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Hospital Admissions (time frame: Compare the number of Hospital Admissions during the 12-month period immediately prior to the index admission to the number of Hospital Admissions during the 12-month period immediately following the study intervention). The study lists 3 primary outcomes in all. 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 17 May 2017.