Measuring Various Variables in Obstructive Sleep Apnea

NCT06284083 | Completed DMC

• 1 other identifier: Cumhuriyet University Hospital
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea-hypopnea Syndrome

Keywords

sleep apnea; agmatine; telomerase; trace elements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Polysomnographic measurement

  one day

Study Arms (2)

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

NO INTERVENTION

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.

Agmatine, Telomerase and Trace element levels measurment

EXPERIMENTAL

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

Interventions

taking a blood sample DIAGNOSTIC_TEST

Blood samples collected from patienst, only 7 mL

Agmatine, Telomerase and Trace element levels measurment

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• asthma
• chronic obstructive pulmonary disease
• pneumonia
• psychiatric
• diabetes
• heart failure
• who work at night work

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Centre, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sevtap BAKIR, Professor

  Cumhuriyet University

  STUDY CHAIR

• Ömer Tamer DOĞAN, Professor

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D,main investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: February 28, 2024
• Study Start: December 18, 2018
• Primary Completion: January 15, 2021
• Study Completion: February 7, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TU (1)