The Effect of Positive Airway Pressure on Heart Rate Variability

This study has been completed.

First Received: February 9, 2006 Last Updated: September 29, 2008 History of Changes

Sponsor:	Christiana Care Health Services
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00289666

Purpose

This study is designed to determine the effect of continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) on heart rate variability (HRV) in patients with obstructive sleep apnea (OSA).

Condition
Obstructive Sleep Apnea

Study Type:	Observational
Study Design:	Observational Model: Case-Only, Time Perspective: Prospective
Official Title:	A Prospective Study to Determine the Effect of Positive Airway Pressure on Heart Rate Variability in Individuals With Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum, Plasma, Urine

Estimated Enrollment:	38
Study Start Date:	July 2003
Study Completion Date:	September 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Tertiary Care

Criteria

Inclusion Criteria:

Individuals aged 18-75 years old.
Individuals with diagnosed OSA.

Exclusion Criteria:

1. Individuals who are receiving treatment for OSA, excluding those being treated by weight loss.

2. Individuals who have had pharyngeal surgery (i.e., uvulopalatopharyngoplasty).

3. Individuals who have arterial oxygen desaturation episodes or apneic episodes not felt to be due to OSA.

4. Individuals whose treatment dosage changes 2 months prior to, or during, the study for antihypertensive and antidiabetic medications and the following medications that may affect the autonomic nervous system: anti-tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol, perhexiline maleate, cordarone, clofibrate, tricyclic antidepressants, phenytoin, barbiturates, neuroleptic drugs, antiparkinsonism drugs, and nitrated drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289666

Locations

United States, Delaware
Christiana Care Health Service
Newark, Delaware, United States, 19713

Sponsors and Collaborators

Christiana Care Health Services

Investigators

Principal Investigator:

Raelene E Maser, PhD

University of Delaware

More Information

Publications:

Maser RE, Lenhard MJ, Rizzo AA, Vasile AA. Continuous positive airway pressure therapy improves cardiovascular autonomic function for persons with sleep-disordered breathing. Chest. 2008 Jan;133(1):86-91. Epub 2007 Oct 20.

Responsible Party:	Christiana Care Health Services ( M James Lenhard, MD )
Study ID Numbers:	23011
Study First Received:	February 9, 2006
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00289666 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:

Sleep Disorder
CPAP

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on March 18, 2010