Measuring Various Variables in Obstructive Sleep Apnea (OUAS)

COMPARİSON OF AGMATİNE, TELOMERASE, AND SOME TRACE ELEMENT LEVELS İN PATİENTS WİTH DİFFERENT SEVERİTY OF OBSTRUCTİVE SLEEP APNEA SYNDROME. Start Date: 18.12.2018

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea-hypopnea Syndrome
• Intervention / Treatment: Diagnostic test: taking a blood sample

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Centre
    • Sivas, Centre, Turkey, 58140
      • Sivas Cumhuriyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Diagnostic test: taking a blood sample; Blood samples collected from patienst, only 7 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity.	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.	not measured in time frame. general (one day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnographic measurement	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.	one day

Collaborators and Investigators

• Sponsor: Cumhuriyet University
• Investigators: Study Chair: Sevtap BAKIR, Professor, Cumhuriyet University; Principal Investigator: Ömer Tamer DOĞAN, Professor, Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: sleep apnea; telomerase; trace elements; agmatine
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: Cumhuriyet University Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No