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WithdrawnNCT01997866Updated May 17, 2017

Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

An interventional study of STOP-BANG Scoring Model and Polysomnogram Sleep Study in Obstructive Sleep Apnea, Sleep Apnea and Congestive Heart Failure, sponsored by University of Florida. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by University of Florida · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Re-evaluate inclusion/exclusion criteria
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 110 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Sleep Apnea
  • Congestive Heart Failure
  • Heart Failure

Keywords

  • Obstructive Sleep Apnea
  • Sleep Apnea
  • Congestive Heart Failure
  • Heart Failure
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 160 are open to participants now.

Browse Apnea studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Patients with Congestive Heart Failure

    STOP-BANG Scoring Model Polysomnogram Sleep Study

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

Interventions

  • OtherSTOP-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.

  • OtherPolysomnogram 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Epworth Sleepiness Scale

    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

    Time frame: Change from Baseline to 6 weeks

  2. Epworth Sleepiness Scale

    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

    Time frame: Change from Baseline to 12 months

  3. 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

    Time frame: Change from Baseline to 3 months

  4. 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

    Time frame: Change from Baseline to 12 months

  5. 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.

    Time frame: at 6 weeks

  6. Epworth Sleepiness Scale

    Chance of Dozing Off - Scale: Never, Slight, Moderate, High

    Time frame: Change from Baseline to 3 months

  7. 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

    Time frame: Change from Baseline to 6 weeks

  8. 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.

    Time frame: at 3 months

  9. 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.

    Time frame: at 12 months

  10. % 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.

    Time frame: at 6 weeks

  11. % 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.

    Time frame: at 3 months

  12. % 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.

    Time frame: at 12 months

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01997866
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Nov 28, 2013
Start date
Jan 2015
Primary completion
Apr 2017 (estimated)
Completion
Apr 2017 (estimated)
Last update
May 17, 2017

Study contacts

Robert Leverence, M.D.
principal investigator · University of Florida
Nila Radhakrishnan, M.D.
study chair · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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