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Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

This study has been withdrawn prior to enrollment.
(Re-evaluate inclusion/exclusion criteria)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01997866
First Posted: November 28, 2013
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
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).

Condition Intervention
Obstructive Sleep Apnea Sleep Apnea Congestive Heart Failure Heart Failure Other: STOP-BANG Scoring Model Other: Polysomnogram Sleep Study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Epworth Sleepiness Scale [ Time Frame: Change from Baseline to 6 weeks ]
    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

  • Epworth Sleepiness Scale [ Time Frame: Change from Baseline to 12 months ]
    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

  • Functional Outcome of Sleep Quality [ Time Frame: Change from Baseline to 3 months ]
    Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty

  • Functional Outcome of Sleep Quality [ Time Frame: Change from Baseline to 12 months ]
    Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty

  • Residual Apnea Hypopnea Index [ Time Frame: at 6 weeks ]
    This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.

  • Epworth Sleepiness Scale [ Time Frame: Change from Baseline to 3 months ]
    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

  • Functional Outcome of Sleep Quality [ Time Frame: Change from Baseline to 6 weeks ]
    Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty

  • Residual Apnea Hypopnea Index [ Time Frame: at 3 months ]
    This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.

  • Residual Apnea Hypopnea Index [ Time Frame: at 12 months ]
    This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.

  • % of nights with greater than 4 hours use of Continuous Positive Airway Pressure [ Time Frame: at 6 weeks ]
    Compliance for a given night would be 4 hours use or more.

  • % of nights with greater than 4 hours use of Continuous Positive Airway Pressure [ Time Frame: at 3 months ]
    Compliance for a given night would be 4 hours use or more.

  • % of nights with greater than 4 hours use of Continuous Positive Airway Pressure [ Time Frame: at 12 months ]
    Compliance for a given night would be 4 hours use or more.


Enrollment: 0
Study Start Date: January 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients with Congestive Heart Failure

STOP-BANG Scoring Model

Polysomnogram Sleep Study

Other: STOP-BANG Scoring Model
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.
Other: Polysomnogram Sleep Study
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patient has:

    1. CHF (systolic, diastolic, any etiology), or
    2. Normal Ejection Fraction (EF) and most recent:

      1. Age less than 50: N-Terminal Pro Brain Natriuretic Peptide (NTPBNP) > 400,
      2. Age 50 and older: NTPBNP > 750,
      3. If no NTPBNP done: then Brain Natriuretic Peptide (BNP) > 200 (some newly referred patients will only have this available at their first visit, or
    3. 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

Exclusion criteria:

  • 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997866


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Robert Leverence, M.D. University of Florida
Study Chair: Nila Radhakrishnan, M.D. University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01997866     History of Changes
Other Study ID Numbers: 201300300
First Submitted: November 1, 2013
First Posted: November 28, 2013
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by University of Florida:
Obstructive Sleep Apnea
Sleep Apnea
Congestive Heart Failure
Heart Failure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Heart Failure
Apnea
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases