Measuring Various Variables in Obstructive Sleep Apnea

NCT ID: NCT06284083

Last Updated: 2024-02-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2022-02-07

Brief Summary

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This study included 90 volunteer Obstructive Sleep Apnea Syndrome patients. Only 7 mL blood samples collected from patients. Some biochemicals parameters analyzed in blood serum/plasma.

Detailed Description

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This study included 90 volunteer patients diagnosed with OSAS, and they were divided into three groups according to the apnea-hypopnea index (AHI) score: mild OSAS (n=30;5≤ AHI ≤13.70), moderate (n=30;15.80≤AHI≤26.60) and severe (n=30;34.10≤AHI≤86.30). Demographic data, as well as biochemical parameters, nocturnal oxygen saturation percentage (SpO2), and body mass index (BMI) were measured. Plasma agmatine levels were measured by ultra-high-pressure liquid chromatography (UHPLC), plasma trace elements (Cu, Co, Mg, Mo, Zn, Se) levels were determind by inductively coupled plasma mass spectrometer (ICP-MS) and serum telomerase levels were measured by enzyme-linked immunosorbent assay (ELISA) method. Analyzes were carried out at the Cumhuriyet University advanced technology research and application center.

Conditions

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Obstructive Sleep Apnea-hypopnea Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study group consisted of 90 newly diagnosed OSAS patients who were admitted to the Clinic for Chest Diseases of the Research and Practice Hospital of Sivas Cumhuriyet University Faculty of Medicine. For the definitive diagnosis of OSAS, the patients were hospitalized overnight in the Sleep Center and polysomnography test was performed. OSAS patients, who were randomly selected without discrimination in terms of age and gender, were connected to the PSG device for one night and various measurements were taken and the values were recorded. The apnea/hypopnea index (AHI) was defined as the sum of the apnea and hypopnea number per hour of sleep. Volunteer patients were grouped into three based on apnea-hypopnea index (AHI) scores: mild OSAS (n=30; 5 ≤ AHI ≤ 13.70), moderate (n=30; 15.80 ≤ AHI ≤ 26.60) and severe (n=30; 34.10 ≤ AHI ≤ 86.30). The mean SpO2 percentages of the PSG device were measured from the fingertip with a system-defined pulse oximeter.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Polysomnographic (PSG) diagnosis and scoring.Oxygen saturation mesurment (SpO2)

The participants were put to sleep with polysomnography (PSG) in the sleep laboratory for 1 night and were divided into 3 groups according to their disease severity. (mild, moderate, severe).The apnea/hypopnea index (AHI) was defined as the sum of the apnea and hypopnea number per hour of sleep. The mean SpO2 percentages of the PSG device were measured from the fingertip with a system-defined pulse oximeter.

Group Type NO_INTERVENTION

No interventions assigned to this group

Agmatine, Telomerase and Trace element levels measurment

With the permission of the participants, 7 ml of venous, fasting blood was taken after the night's sleep.In the blood serum of the participants, agmatine, telomerase, and trace element levels were measured with a commercial ELISA kit.

Group Type EXPERIMENTAL

taking a blood sample

Intervention Type DIAGNOSTIC_TEST

Blood samples collected from patienst, only 7 mL

Interventions

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taking a blood sample

Blood samples collected from patienst, only 7 mL

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of obstructive sleep apnea disease
* Apnea-hypopnea index (AHI) score between 5-87

Exclusion Criteria

* asthma
* chronic obstructive pulmonary disease
* pneumonia
* psychiatric
* diabetes
* heart failure
* who work at night work
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

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Dilara Ulger Ozbek

Ph.D,main investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevtap BAKIR, Professor

Role: STUDY_CHAIR

Cumhuriyet University

Ömer Tamer DOĞAN, Professor

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Locations

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Sivas Cumhuriyet University

Sivas, Centre, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Cumhuriyet University Hospital

Identifier Type: -

Identifier Source: org_study_id

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