Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

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).

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Obstructive Sleep Apnea; Sleep Apnea; Congestive Heart Failure
• Intervention / Treatment: Other: STOP-BANG Scoring Model; Other: Polysomnogram Sleep Study

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Hospital Admissions	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	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	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

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale	Chance of Dozing Off - Scale: Never, Slight, Moderate, High	Change from Baseline to 6 weeks
Epworth Sleepiness Scale	Chance of Dozing Off - Scale: Never, Slight, Moderate, High	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	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	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.	at 6 weeks
Epworth Sleepiness Scale	Chance of Dozing Off - Scale: Never, Slight, Moderate, High	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	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.	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.	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.	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.	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.	at 12 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Robert Leverence, M.D., University of Florida; Study Chair: Nila Radhakrishnan, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; Obstructive Sleep Apnea; Sleep Apnea; Congestive Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Heart Failure; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 201300300