Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

This study has suspended participant recruitment.
(Re-evaluate inclusion/exclusion criteria)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01997866
First received: November 1, 2013
Last updated: May 28, 2015
Last verified: May 2015
  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: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Epworth Sleepiness Scale [ Time Frame: Change from Baseline to 6 weeks ] [ Designated as safety issue: No ]
    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

  • Epworth Sleepiness Scale [ Time Frame: Change from Baseline to 12 months ] [ Designated as safety issue: No ]
    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

  • Functional Outcome of Sleep Quality [ Time Frame: Change from Baseline to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

  • Functional Outcome of Sleep Quality [ Time Frame: Change from Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Compliance for a given night would be 4 hours use or more.


Estimated Enrollment: 700
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01997866     History of Changes
Other Study ID Numbers: 201300300
Study First Received: November 1, 2013
Last Updated: May 28, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 27, 2015