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| Sponsored by: |
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 |
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Obstructive Sleep Apnea |
| MedlinePlus related topics: | Sleep Apnea |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | A Prospective Study to Determine the Effect of Positive Airway Pressure on Heart Rate Variability in Individuals With Obstructive Sleep Apnea |
Serum, Plasma, Urine
| Estimated Enrollment: | 38 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | August 2008 |
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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 |
Tertiary Care
Inclusion Criteria:
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| United States, Delaware | |||||
| Christiana Care Health Service | |||||
| Newark, Delaware, United States, 19713 | |||||
| Christiana Care Health Services |
| Principal Investigator: | Raelene E Maser, PhD | University of Delaware |
More Information
| Responsible Party: | Christiana Care Health Services ( M James Lenhard, MD ) |
| Study ID Numbers: | 23011 |
| First Received: | February 9, 2006 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00289666 |
| Health Authority: | United States: Institutional Review Board |
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