Measuring Various Variables in Obstructive Sleep Apnea

Obstructive Sleep Apnea-hypopnea Syndrome Clinical Trial

— OUAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06284083
• Other study ID #: Cumhuriyet University Hospital
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: February 7, 2022

Study information

• Verified date: February 2024
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 7, 2022
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea-hypopnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Diagnostic Test:
• taking a blood sample
Blood samples collected from patienst, only 7 mL

Locations

Country	Name	City	State
Turkey	Sivas Cumhuriyet University	Sivas	Centre

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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