Effects of Treating Sleep Apnea in Patients Hospitalized With Congestive Heart Failure

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01997866
First received: November 1, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

Patients hospitalized with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services 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.


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 Hospitalized 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 6-month period immediately prior to the index admission to the number of Hospital Admissions during the 6-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 6-month period immediately prior to the index admission to the number of Hospitalized Days during the 6-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 6-month period immediately prior to the index admission to the number of Emergency Department Visits during the 6-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

  • 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

  • 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.

  • % 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.


Estimated Enrollment: 600
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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 hospitalized with Congestive Heart Failure on non-Intensive Care Unit Medical Services 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 have Polysomnogram Sleep Study at the Sleep Center and be referred to the Sleep Center physicians for evaluation and treatment.

Detailed Description:

Patients hospitalized with Congestive Heart Failure on non-Intensive Care Unit Medical Services will be screened using the STOP-BANG Scoring Model. Patients with high risk of Obstructive Sleep Apnea will have Polysomnogram performed at the Sleep Center, then be referred to the Sleep Center physicians for evaluation and treatment. Patients will be followed for up to one year to determine if the screening and 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:

  • Admission for decompensated Congestive Heart Failure
  • Admitted to the non-Intensive Care Medical Services (North Tower only)
  • Patient must have at least 2 encounters (Emergency Department Visit, Inpatient Admission, Observation Admission) with UF Health during the 6-month period immediately prior to the index admission
  • English Speaking
  • Males and Females
  • Age 18 to 110
  • Ability to understand and complete consent process
  • Agreement to return to Gainesville for regular follow-up visits

Exclusion criteria:

  • Drug/Alcohol abuse - Evidence of current use
  • Previous diagnosis of sleep apnea and on current treatment
  • Severe Lung disease as judged by attending physician
  • Uncontrolled Ventricular Dysrhythmias; sustained episodes of ventricular tachycardia or ventricular fibrillation in the hospital
  • Evidence of active ischemia evidenced by increased Triponin unrelated to Chronic Kidney Disease, or < 6 weeks since myocardial infarction
  • Palliative care or Life expectancy < 6 months
  • Isolated Cor Pulmonale - predominantly right ventricular dysfunction, and/or on the following medications for pulmonary hypertension: sildenafil (Viagra®), tadalafil (Adcirca®, Cialis®), treprostinil (Remodulin®; Tyvaso™), ambrisentan (Letairis®), bosentan (Tracleer®), epoprostenol, inhaled iloprost (Ventavis®)
  • On more than 3 liters of oxygen
  • R-R Interval > 18
  • Self-Pay Status
  • Known Pregnancy
  • Vulnerable Subjects such as prisoners, decisionally impaired/comatose individuals, terminally ill patients, University of Florida/Shands/Veterans Administration staff, University of Florida 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

Contacts
Contact: Robert Leverence, M.D. robert.leverence@medicine.ufl.edu
Contact: Irfan Nasir, M.D. inasir@ufl.edu

Locations
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Robert Leverence, M.D.       robert.leverence@medicine.ufl.edu   
Contact: Irfan Nasir, M.D.       inasir@ufl.edu   
Principal Investigator: Robert Leverence, M.D.         
Sub-Investigator: Irfan Nasir, M.D.         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Robert Leverence, M.D. University of Florida
Study Chair: Irfan Nasir, 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 27, 2014
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:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014