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

NCT00679822 | Completed

• 1 other identifier: 2007H0043
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea; Heart Failure

Keywords

OSA; sleep apnea; heart failure; CHF; heart clinic; clinic; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Validation of Inpatient Portable Sleep Study

  Patients at risk of Sleep Disordered Breathing with heart failure are administered a portable sleep study during their hospitalization

  Baseline

Study Arms (1)

Heart Failure

Heart Failure Out Patients at OSU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-patients at OSU's Heart Failure clinics

You may qualify if:

• OSU Heart Failure Patient
• Willingness to complete survey
• Willingness to complete take home sleep study

You may not qualify if:

• Neurological deficit
• Less than 18yrs old

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43212, United States

Location

Related Publications (11)

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  PMID: 8464434 BACKGROUND

• Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.

  PMID: 9626176 BACKGROUND

• Sin DD, Fitzgerald F, Parker JD, Newton G, Floras JS, Bradley TD. Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med. 1999 Oct;160(4):1101-6. doi: 10.1164/ajrccm.160.4.9903020.

  PMID: 10508793 BACKGROUND

• Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.

  PMID: 15781100 BACKGROUND

• Mansfield DR, Gollogly NC, Kaye DM, Richardson M, Bergin P, Naughton MT. Controlled trial of continuous positive airway pressure in obstructive sleep apnea and heart failure. Am J Respir Crit Care Med. 2004 Feb 1;169(3):361-6. doi: 10.1164/rccm.200306-752OC. Epub 2003 Nov 3.

  PMID: 14597482 BACKGROUND

• Spaak J, Egri ZJ, Kubo T, Yu E, Ando S, Kaneko Y, Usui K, Bradley TD, Floras JS. Muscle sympathetic nerve activity during wakefulness in heart failure patients with and without sleep apnea. Hypertension. 2005 Dec;46(6):1327-32. doi: 10.1161/01.HYP.0000193497.45200.66. Epub 2005 Nov 14.

  PMID: 16286569 BACKGROUND

• Leung RS, Huber MA, Rogge T, Maimon N, Chiu KL, Bradley TD. Association between atrial fibrillation and central sleep apnea. Sleep. 2005 Dec;28(12):1543-6. doi: 10.1093/sleep/28.12.1543.

  PMID: 16408413 BACKGROUND

• Solin P, Bergin P, Richardson M, Kaye DM, Walters EH, Naughton MT. Influence of pulmonary capillary wedge pressure on central apnea in heart failure. Circulation. 1999 Mar 30;99(12):1574-9. doi: 10.1161/01.cir.99.12.1574.

  PMID: 10096933 BACKGROUND

• Sinha AM, Skobel EC, Breithardt OA, Norra C, Markus KU, Breuer C, Hanrath P, Stellbrink C. Cardiac resynchronization therapy improves central sleep apnea and Cheyne-Stokes respiration in patients with chronic heart failure. J Am Coll Cardiol. 2004 Jul 7;44(1):68-71. doi: 10.1016/j.jacc.2004.03.040.

  PMID: 15234409 BACKGROUND

• Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.

  PMID: 16282177 BACKGROUND

• Tamura A, Kawano Y, Naono S, Kotoku M, Kadota J. Relationship between beta-blocker treatment and the severity of central sleep apnea in chronic heart failure. Chest. 2007 Jan;131(1):130-5. doi: 10.1378/chest.06-0919.

  PMID: 17218566 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Rami N Khayat, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: June 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

US (1)