The Effect of Positive Airway Pressure on Heart Rate Variability

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00289666
First received: February 9, 2006
Last updated: September 29, 2008
Last verified: September 2008
  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:


Further study details as provided by Christiana Care Health Services:

Biospecimen Retention:   Samples Without DNA

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Christiana Care Health Services:
Sleep Disorder
CPAP

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 29, 2014