Evaluation of Prolidase in Obstructive Sleep Apnea Syndrome

NCT ID: NCT03563118

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-12-01

Brief Summary

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Obstructive sleep apnea (OSA) is a highly prevalent breathing disorder in sleep. We have aimed to evaluate the relationship between OSA and prolidase activity, the oxidative stress index (OSI), total antioxidative capacity (TAC), and total oxidative capacity (TOC) and the relationship between carotid intima media thickness (CIMT).

Detailed Description

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This study was approved by the local ethics committee in accordance with the Helsinki Declaration. Written informed consent was received from the OSAS Subjects patients and control subjects before enrolment in the study. The patient and control cohorts were recruited from the Pulmonary Medicine Department, Medical Faculty, Yuzuncu Yıl University. Blood samples were analysed at the Biochemistry Laboratory of Harran University Medical Faculty TAC and TOS levels were measured by using an automated measurement method. TAC measurement method involves the production of a potent biological hydroxyl radical. Ferrous ion solution is mixed with hydrogen peroxide. Thus, it is possible to measure the anti-oxidative effect of the sample against the potent free radical reactions initiated by the production of the hydroxyl radical. TOS method is based on the oxidation of ferrous ion to ferric ion in the presence of various oxidant species in acidic medium and the measurement of the ferric ion by xylenol orange. mmol Trolox equivalent (equiv)/L, mmol H2O2 /L and mg/dL, respectively.

Conditions

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Obstructive Sleep-Apnea Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group OSAS

We included 56 with OSAS \[13 subjects 23.2% mild, 19 subjects 33.9% moderate, 24 subjects 42.8% severe

No interventions assigned to this group

control group

simple snoring

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients were diagnosed with OSA after night polysomnography (PSG).
* Patients were enrolled in the study following receipt of their written informed consent.

Exclusion Criteria

* Patients had ischaemic cardiovascular diseases,
* Patients had chronic obstructive pulmonary diseases,
* Patients had ischaemic cerebral diseases,
* Patients had chronic inflammatory diseases,
* Patients had chronic and acute systemic infections.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Havva Sayhan

assiatant prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Havva Sayhan

Role: STUDY_CHAIR

Sakarya University Research and Training Hospital

Locations

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Sakarya University Research and Training Hospital

Sakarya, Merkez, Turkey (Türkiye)

Site Status RECRUITING

Sakarya University Research and Training Hospital

Sakarya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Havva Sayhan

Role: CONTACT

+905056621021

hulya gunbatar, asso. prof.

Role: CONTACT

+905065118827

Facility Contacts

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Havva Sayhan, Assis Prof

Role: primary

+905056621021

hulya gunbatar, assosiate. prof.

Role: backup

+905065118827

Havva Sayhan, Assis Prof

Role: primary

+905056621021

müge yılmaz

Role: backup

References

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Yamauchi M, Nakano H, Maekawa J, Okamoto Y, Ohnishi Y, Suzuki T, Kimura H. Oxidative stress in obstructive sleep apnea. Chest. 2005 May;127(5):1674-9. doi: 10.1378/chest.127.5.1674.

Reference Type BACKGROUND
PMID: 15888845 (View on PubMed)

Other Identifiers

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OSAS

Identifier Type: -

Identifier Source: org_study_id

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