Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE (OSAS)
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| First Received Date ICMJE | July 4, 2012 | ||||
| Last Updated Date | July 6, 2012 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01635699 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE (OSAS) | ||||
| Official Title ICMJE | Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE | ||||
| Brief Summary | The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS- on oxidative damage. |
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| Detailed Description | Obstructive sleep apnea syndrome (OSAS) is a sydrome which has characteristic upper way obstruction and a decrease in blood oxygen saturation as sleeping. uvulopalatopharngoplasty (UPPP)is one of the surgical approaches applied to the patients with OSAS, since the oxidative damage markers have been found high in patients with OSAS. Although antioxidant levels were higher in patients with OSAS than those in normal population, there is report about the effect of UPPP on antioxidant status in patients with OSAS. We performed this study to confirm whether is there a We performed the present study to confirm whether there is a relationship between the OSAS and oxidative damage before and after UPPP. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: serum, whole blood |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS) at the otolaryngology department of our hospital in Erzurum, Turkey. |
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| Condition ICMJE | Sleep Apnea, Obstructive | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 49 | ||||
| Completion Date | March 2011 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Turkey | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01635699 | ||||
| Other Study ID Numbers ICMJE | ATUNI-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Vural Fidan, Erzurum Regional Training & Research Hospital | ||||
| Study Sponsor ICMJE | Erzurum Regional Training & Research Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Erzurum Regional Training & Research Hospital | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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