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NCT00679822 · ClinicalTrials.gov registry record

The Prevalence and Risk Factors of Sleep Disordered Breathing in a Heart Failure Program

A clinical trial of Heart Failure and Sleep Apnea, sponsored by Ohio State University.

Completed
Registry status
195
Enrollment target
1
Study location

NCT00679822 is a study of Heart Failure and Sleep Apnea that has completed, run by Ohio State University. The registered enrollment target is 195 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00679822, a study of Heart Failure and Sleep Apnea, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
195 participants
Enrollment target
1
Study location

Study Summary

The objective of this protocol is the evaluation of our clinical screening program for sleep disorders in patients with heart failure. These patients have very high prevalence of Sleep Disordered Breathing (SDB), including central and obstructive sleep apnea. There is also strong evidence that SDB, if unrecognized and untreated, will worsen heart failure and may leads to serious complications. Effective treatment of SDB results in improvement in heart failure and functional status. So far there are no guidelines in the area of screening in this patient population. The only test that would reliably rule out or confirm SDB is the polysomnography (PSG) this test is expensive and technically demanding. With the current approach to diagnosis and treatment of SDB, it routinely takes up to 5-6 months between the emergence of clinical suspicion of SDB and the initiation of appropriate treatment with CPAP. This delay and cost of this traditional approach, is a significant obstacle to providing highly needed care to this very vulnerable population. In OSU we have a state of the art Heart Failure Program and a Sleep Heart program that was created to develop an approach to prompt diagnosis and treatment of SDB in our heart failure patients. We designed an algorithm that employs validated questionnaires and FDA approved devices. We need, however to validate our algorithm against the gold standard: the PSG. Furthermore, we need to analyze the prevalence and risk factors of each sleep disorder in light of the recent changes in the management of heart failure, which may have influenced the risk factors and prevalence as we knew them. This protocol includes a combination of clinically indicated procedures, and others that are repeated for validation purposes. The accumulation and analysis of data is also done for research purposes.

Study Locations (1)

Ohio

  • The Ohio State University - Columbus

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2007-06
Est. Completion 2013-07

Sponsor

Ohio State University

552 total trials

What the Registry Record Tells You About NCT00679822

The ClinicalTrials.gov registry entry for NCT00679822 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 0 interventions.

NCT00679822 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT00679822 about?

NCT00679822 is a clinical study titled "The Prevalence and Risk Factors of Sleep Disordered Breathing in a Heart Failure Program". The objective of this protocol is the evaluation of our clinical screening program for sleep disorders in patients with heart failure. These patients have very high prevalence of Sleep Disordered Breathing (SDB), including central and obstructive sleep apnea. There is also strong evidence that SDB,...

What is the current status of trial NCT00679822?

This trial is currently completed. The enrollment target is 195 participants. The study started on 2007-06. Estimated completion is 2013-07.

What conditions does trial NCT00679822 study?

This clinical trial studies the following conditions: Heart Failure, Sleep Apnea.

Who is sponsoring clinical trial NCT00679822?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00679822 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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