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Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

Primary Purpose

Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STOP-BANG Scoring Model
Polysomnogram Sleep Study
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure, Heart Failure

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with Congestive Heart Failure

Arm Description

STOP-BANG Scoring Model Polysomnogram Sleep Study

Outcomes

Primary Outcome Measures

Number of Hospital Admissions
Number of Hospitalized Days
Number of Emergency Department Visits

Secondary Outcome Measures

Epworth Sleepiness Scale
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Epworth Sleepiness Scale
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
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
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
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.
Epworth Sleepiness Scale
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
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
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.
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.
% 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.
% 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.
% 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.

Full Information

First Posted
November 1, 2013
Last Updated
May 16, 2017
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01997866
Brief Title
Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure
Official Title
Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Re-evaluate inclusion/exclusion criteria
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure, Heart Failure
Keywords
Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure, Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Congestive Heart Failure
Arm Type
Other
Arm Description
STOP-BANG Scoring Model Polysomnogram Sleep Study
Intervention Type
Other
Intervention Name(s)
STOP-BANG Scoring Model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Polysomnogram Sleep Study
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Measure Information:
Title
Epworth Sleepiness Scale
Description
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Time Frame
Change from Baseline to 6 weeks
Title
Epworth Sleepiness Scale
Description
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Time Frame
Change from Baseline to 12 months
Title
Functional Outcome of Sleep Quality
Description
Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty
Time Frame
Change from Baseline to 3 months
Title
Functional Outcome of Sleep Quality
Description
Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty
Time Frame
Change from Baseline to 12 months
Title
Residual Apnea Hypopnea Index
Description
This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.
Time Frame
at 6 weeks
Title
Epworth Sleepiness Scale
Description
Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Time Frame
Change from Baseline to 3 months
Title
Functional Outcome of Sleep Quality
Description
Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty
Time Frame
Change from Baseline to 6 weeks
Title
Residual Apnea Hypopnea Index
Description
This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.
Time Frame
at 3 months
Title
Residual Apnea Hypopnea Index
Description
This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.
Time Frame
at 12 months
Title
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Description
Compliance for a given night would be 4 hours use or more.
Time Frame
at 6 weeks
Title
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Description
Compliance for a given night would be 4 hours use or more.
Time Frame
at 3 months
Title
% of nights with greater than 4 hours use of Continuous Positive Airway Pressure
Description
Compliance for a given night would be 4 hours use or more.
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Leverence, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nila Radhakrishnan, M.D.
Organizational Affiliation
University of Florida
Official's Role
Study Chair
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

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