- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07571941
Effects of CO Level on Pain, Sensory Function, and Subjective Health
Evaluation of the Effects of Carbon Monoxide (CO) Levels on Pain Threshold, Sensory Function, Anxiety, Depression, and Subjective Health Complaints
Carbon monoxide (CO) is a colorless and odorless gas that can enter the human body through environmental exposure and especially tobacco use. CO binds to hemoglobin with a much higher affinity than oxygen, thereby reducing oxygen transport to tissues. This condition may lead to various physiological and psychological effects, particularly on the nervous system.
In the literature, CO exposure has mainly been investigated in the context of acute poisoning cases and smoking-related effects. However, studies evaluating the effects of low-level and chronic CO exposure-more commonly encountered in the general population-on pain perception, sensory functions, and psychological status are limited.
Tobacco smoke is an important source of CO, and exhaled CO levels have been shown to be significantly higher in smokers and associated with various neurocognitive changes. Evidence suggests that CO exposure may influence anxiety, depression, attention, and cognitive functions. In addition, some studies indicate that CO may affect brain regions involved in pain perception and emotional regulation.
However, there is insufficient research examining the relationship between low-level carbon monoxide exposure and pain threshold, sensory functions, anxiety, depression, and subjective health complaints within the same study framework.
This study aims to evaluate the relationship between exhaled carbon monoxide (CO) levels and pain threshold, sensory functions, anxiety, depression, and subjective health complaints in healthy adults. By examining the multidimensional effects of low-level CO exposure, the study seeks to fill an important gap in the literature and provide a more comprehensive understanding of this issue.
Přehled studie
Postavení
Detailní popis
Carbon monoxide (CO) is a colorless, odorless, and toxic gas that can adversely affect human health through both environmental and behavioral exposure pathways. In the literature, most studies on CO exposure have focused on acute poisoning cases and smoking cessation processes. In contrast, research addressing the physiological and psychological effects of chronic low-level CO exposure, which is more commonly encountered in the general population, remains limited.
According to the World Health Organization (WHO), tobacco use causes approximately 8 million deaths annually and represents a major public health concern. CO, one of the main components of tobacco smoke, binds to hemoglobin with a much higher affinity than oxygen, impairing oxygen transport to tissues and leading to systemic hypoxia. This condition has particularly pronounced effects on the central nervous system.
Studies on the neurological and psychiatric outcomes of CO exposure have reported that cognitive impairments, anxiety, and depressive symptoms are frequently observed following acute poisoning. Significant associations have also been demonstrated between the severity of poisoning and the level of depressive and anxious symptoms. In addition, voxel-based morphometry studies have reported that CO exposure may lead to reductions in gray matter volume in brain regions associated with pain perception and emotional regulation, such as the frontal lobe, cerebellum, and periaqueductal gray matter.
In studies involving smokers, exhaled CO levels have been shown to be significantly higher compared to non-smokers and positively correlated with daily cigarette consumption. Even at low carboxyhemoglobin levels, neurological effects such as visual perception impairments, attention deficits, learning difficulties, and reduced motor performance have been reported.
At the molecular level, CO is thought to induce oxidative stress and neuroinflammatory processes, potentially leading to neuronal damage. These mechanisms may influence pain perception, sensory functions, and emotional status. However, studies simultaneously evaluating the relationship between chronic low-level CO exposure and pain threshold, sensory function, anxiety, depression, and subjective health complaints are still insufficient.
In this context, the planned study aims to systematically and comprehensively evaluate the relationships between exhaled carbon monoxide (CO) levels and pain threshold, sensory functions, anxiety, depression, and subjective health complaints in healthy adults. The study is expected to fill an important gap in the literature by shedding light on the multidimensional effects of chronic low-level CO exposure and contributing novel insights to the scientific knowledge base.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Betül Taşpınar, Professor
- Telefonní číslo: +90 506 680 44 26
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Being between the ages of 18 and 65
Having a regular smoking history for the past 6 months
No history of respiratory, cardiovascular, or neurological/psychiatric diseases
No recent surgery or trauma that could affect respiratory muscles
Not having an acute infection (especially upper or lower respiratory tract infection)
Exclusion Criteria:
-
Having chronic respiratory diseases such as COPD or asthma
Having a history of cardiovascular disease
Having a diagnosed neurological or psychiatric disorder
Having a history of surgery or trauma affecting respiratory muscles within the last 3 months
Being pregnant or having a suspicion of pregnancy
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Healthy Adults - CO Exposure
This cohort includes healthy adult participants.
No intervention is applied.
Participants will be assessed for exhaled carbon monoxide (CO) levels, pain threshold, sensory functions, anxiety, depression, and subjective health complaints.
The study aims to investigate the association between low-level CO exposure and physiological and psychological outcomes.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Exhaled Carbon Monoxide (CO) Level
Časové okno: June 2026- July 2026
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Exhaled carbon monoxide levels will be measured using a Bedfont Smokerlyzer-piCO+ device. Participants will be instructed to take a deep breath, hold their breath for 15 seconds, and then exhale slowly and completely into the device mouthpiece. The measured CO values will be classified as follows: 0-6 ppm: non-smoker 7-10 ppm: light exposure 11-15 ppm: regular smoker 16-25 ppm: heavy smoker 25 ppm: very heavy smoker |
June 2026- July 2026
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pain Threshold Measurement
Časové okno: June 2026- July 2026
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Pressure pain thresholds will be assessed using an algometer, which is a validated and reliable tool for measuring muscle and soft tissue sensitivity.
The device consists of a 1 cm diameter rubber-tipped metal probe attached to a pressure gauge measuring force in kilograms and pounds.
Pressure pain thresholds will be measured bilaterally at the upper, middle, and lower portions of the trapezius muscle
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June 2026- July 2026
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Beck Anxiety Inventory (BAI)
Časové okno: June 2026- July 2026
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Anxiety levels will be assessed using the Beck Anxiety Inventory, a 21-item self-report questionnaire.
Each item will be scored between 0 and 3, with total scores ranging from 0 to 63.
Higher scores will indicate greater anxiety severity.
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June 2026- July 2026
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Beck Depression Inventory (BDI)
Časové okno: June 2026- July 2026
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Depressive symptoms will be evaluated using the Beck Depression Inventory, a 21-item self-report scale assessing cognitive, emotional, motivational, and somatic symptoms of depression.
Each item will be scored from 0 to 3, with total scores ranging from 0 to 63.
Higher scores will indicate more severe depressive symptoms.
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June 2026- July 2026
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Semmes-Weinstein Monofilament Test
Časové okno: June 2026- July 2026
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Sensory function will be assessed using the Semmes-Weinstein monofilament test, a widely used method for evaluating light touch and pressure perception.
Monofilaments ranging from 0.086 gm to 448 gm will be applied in ascending order.
Testing will be performed from distal to proximal regions, including the anterior and posterior surfaces of all fingers.
The smallest detectable monofilament will be recorded.
When the filament bends, the applied force will be considered constant, and participants' perception will be recorded accordingly
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June 2026- July 2026
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Subjective Health Complaints Inventory
Časové okno: June 2026-July 2026
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Physical and psychological health complaints will be assessed using the Subjective Health Complaints Inventory, a self-report questionnaire developed in Norway and widely used internationally.
The scale consists of 29 items rated from 0 (none) to 3 (severe), covering symptoms experienced during the last 30 days.
Total scores will range from 0 to 87, with higher scores indicating more complaints.
The scale includes five subdomains: musculoskeletal, pseudoneurological, gastrointestinal, allergy, and flu-like symptoms.
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June 2026-July 2026
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Fagerström Test for Nicotine Dependence
Časové okno: June 2026- July 2026
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Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence, a 6-item self-report questionnaire.
Total scores will range from 0 to 10.
Based on the score, participants will be classified as very low, low, moderate, high, or very high dependence.
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June 2026- July 2026
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026/3-6
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