Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea; Sleep Apnea; Congestive Heart Failure; Heart Failure
• Interventions: Other: STOP-BANG Scoring Model; Other: Polysomnogram Sleep Study

• Registration Number: NCT01997866
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Study Start: 2015-01
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Congestive Heart Failure	STOP-BANG Scoring Model	STOP-BANG Scoring Model Polysomnogram Sleep Study
Patients with Congestive Heart Failure	Polysomnogram Sleep Study	STOP-BANG Scoring Model Polysomnogram Sleep Study

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Residual Apnea Hypopnea Index	at 12 months	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	at 12 months	Compliance for a given night would be 4 hours use or more.
Epworth Sleepiness Scale	Change from Baseline to 3 months	Chance of Dozing Off - Scale: Never, Slight, Moderate, High
Functional Outcome of Sleep Quality	Change from Baseline to 6 weeks	Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States