CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 195 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00679822
NCT00679822N/ACompleted

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

Ohio State University·observational·Posted May 19, 2008·Updated Feb 13, 2014

In Brief

An observational study for Sleep Apnea and Heart Failure. Completed, enrolled 195 participants across 1 site.

Detailed 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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2008
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 18.1 years ago