Clinical trial NCT06284083: Measuring Various Variables in Obstructive Sleep Apnea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea-hypopnea Syndrome
Keywords: sleep apnea
agmatine
telomerase
trace elements
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity.
timeFrame: not measured in time frame. general (one day)
Secondary outcomes:
measure: Polysomnographic measurement
timeFrame: one day
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
state: Centre
Study officials:
affiliation: Cumhuriyet University
name: Sevtap BAKIR, Professor
role: STUDY_CHAIR
affiliation: Cumhuriyet University
name: Ömer Tamer DOĞAN, Professor
role: PRINCIPAL_INVESTIGATOR
References: