Measuring Various Variables in Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea-hypopnea Syndrome
• Interventions: Diagnostic Test: taking a blood sample

• Registration Number: NCT06284083
• Lead Sponsor: Cumhuriyet University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-12-18
• Primary Completion: 2021-01-15
• Study Completion: 2022-02-07
• Study First Submitted: 2022-08-12
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Agmatine, Telomerase and Trace element levels measurment	taking a blood sample	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.

Primary Outcome Measures

Name	Time	Method
Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity.	not measured in time frame. general (one day)	Agmatine Telomerase and trace element levels will be measured in blood serum. The most common side effect when blood is taken from the patient is slight bruising and swelling in the arm due to needle sticking. There will be no other serious side effects.

Secondary Outcome Measures

Name	Time	Method
Polysomnographic measurement	one day	Patients will be put to sleep for 1 night with polysomnography, and the severity of the disease will be determined by calculating the number of times breathing stops during sleep with the Apnea-hypoapnea index. There will be no side effects.

Trial Locations

Locations (1)

Sivas Cumhuriyet University; 🇹🇷 Sivas, Centre, Turkey