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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT00679822

Public ClinicalTrials.gov record NCT00679822. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 9:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00679822
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Ohio State University
Other
Enrollment
195 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2007
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013
Last update posted
Feb 12, 2014

2007 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The Ohio State University Columbus Ohio 43212

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00679822, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 12, 2014 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00679822 live on ClinicalTrials.gov.

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