Sleep Apnea, ObstructiveNCT01635699
Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE (OSAS)
An observational study of Sleep Apnea, Obstructive, run by Erzurum Regional Training & Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2008to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS) at the otolaryngology department of our hospital in Erzurum, Turkey.
Who may be able to join
- Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS)
Who cannot join
- Anormal nasopharyngeal computed tomography, chronic diseases such as diabetes mellitus, hypertension etc.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Regional Educational Researh Hospital
Erzurum, Erzurum, 25000
About this study
Official title: Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- DNA oxidation, obstructive sleep apnea, lipid peroxidation, oxidative stresses
- Medical subject headings
- Sleep Apnea, Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJun 2008
- Primary completionJun 2008
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Regional Training & Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vural Fidan, Erzurum Regional Training & Research Hospital
- Investigators
- vural fidan, operating surgeon doctor, Principal investigator, eskisehir yunus emre state hospital (still works here)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635699
- Sponsor's protocol ID
- ATUNI-1
- Status last verified
- Jul 2012
- First submitted
- 4 Jul 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakan E, Fidan V, Alp HH, Baygutalp NK, Cokluk E. Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea Syndrome. J Craniofac Surg. 2015 Jul;26(5):e392-6. doi: 10.1097/SCS.0000000000001870.
PubMed 26163849
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE
- ClinicalTrials.gov ID
- NCT01635699
- Acronym / sponsor ID
- ATUNI-1
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- DNA oxidation, obstructive sleep apnea, lipid peroxidation, oxidative stresses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Erzurum Regional Training & Research HospitalOther government
- Study start
- Jun 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS) at the otolaryngology department of our hospital in Erzurum, Turkey.
Key inclusion criteria (1 listed)
- Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS)
Key exclusion criteria (1 listed)
- Anormal nasopharyngeal computed tomography, chronic diseases such as diabetes mellitus, hypertension etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Derived from this study: PubMed 26163849Bakan E, Fidan V, Alp HH, Baygutalp NK, Cokluk E. Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea Syndrome. J Craniofac Surg. 2015 Jul;26(5):e392-6. doi: 10.1097/SCS.0000000000001870.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
vural fidan, operating surgeon doctor principal investigator
eskisehir yunus emre state hospital (still works here)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Erzurum Regional Training & Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2012.