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The Effect of Positive Airway Pressure on Heart Rate Variability

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289666
First Posted: February 10, 2006
Last Update Posted: July 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raelene Maser, Christiana Care Health Services
  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 Raelene Maser, 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
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Raelene Maser, Associate Professor, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00289666     History of Changes
Other Study ID Numbers: 23011
First Submitted: February 9, 2006
First Posted: February 10, 2006
Last Update Posted: July 11, 2016
Last Verified: September 2008

Keywords provided by Raelene Maser, Christiana Care Health Services:
Sleep Disorder
CPAP

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