Obstructive Sleep Apnea-hypopnea SyndromeOUASNCT06284083
Measuring Various Variables in Obstructive Sleep Apnea
A study testing taking a blood sample in people with Obstructive Sleep Apnea-hypopnea Syndrome, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Obstructive Sleep Apnea-hypopnea Syndrome
- What is being tested?
- taking a blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2018to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of obstructive sleep apnea disease
- Apnea-hypopnea index (AHI) score between 5-87
Who cannot join
- asthma
- chronic obstructive pulmonary disease
- pneumonia
- psychiatric
- diabetes
- heart failure
- who work at night work
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Centre, 58140
About this study
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
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.
Read the 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.
- Being tested
- taking a blood sample
- Keywords
- sleep apnea, agmatine, telomerase, trace elements
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking a blood sampleDiagnostic test
Blood samples collected from patienst, only 7 mL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: taking a blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: not measured in time frame. general (one day)
Secondary outcomes (1)
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start18 Dec 2018
- Primary completion15 Jan 2021
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea-hypopnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Ulger Ozbek, Cumhuriyet University
- Investigators
- Sevtap BAKIR, Professor, Study chair, Cumhuriyet UniversityÖmer Tamer DOĞAN, Professor, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284083
- Sponsor's protocol ID
- Cumhuriyet University Hospital
- Acronym
- OUAS
- Status last verified
- Feb 2024
- First submitted
- 12 Aug 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06284083
- Acronym / sponsor ID
- OUAS / Cumhuriyet University Hospital
- Keywords
- sleep apnea, agmatine, telomerase, trace elements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: taking a blood sampleWith 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of obstructive sleep apnea disease
- Apnea-hypopnea index (AHI) score between 5-87
Key exclusion criteria (7 listed)
- asthma
- chronic obstructive pulmonary disease
- pneumonia
- psychiatric
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking a blood sampleBlood samples collected from patienst, only 7 mL | Diagnostic test | Agmatine, Telomerase and Trace element levels measurment |
Primary outcome
Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity.
Time frame: 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.
1 secondary outcome
Polysomnographic measurement
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Related trials for Obstructive Sleep Apnea-hypopnea Syndrome
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Not yet recruiting
Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
Obstructive Sleep Apnea
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevtap BAKIR, Professor study chair
Cumhuriyet University
Ömer Tamer DOĞAN, Professor principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taking a blood sample in people with Obstructive Sleep Apnea-hypopnea Syndrome, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity. (time frame: not measured in time frame. general (one day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.