Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco SmokingNCT07571941
Effects of CO Level on Pain, Sensory Function, and Subjective Health
An observational study of Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco Smoking, run by Izmir Democracy University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco Smoking
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include healthy adult participants aged 18-65 years with a history of regular smoking for at least the past 6 months. Participants will be free of respiratory, cardiovascular, neurological, and psychiatric diseases, and will not have any acute infection or recent surgery affecting respiratory muscles.
Who may be able to join
- 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)
Who cannot join
- -
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Betül Taşpınar, Professor contact
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco Smoking
- Keywords
- CO exposure, exhaled carbon monoxide, pain threshold, sensory function, smoking and CO, healthy adults
- Medical subject headings
- Anxiety Disorders, Depression, Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Carbon Monoxide (CO) Level
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
Measured: June 2026- July 2026
Secondary outcomes (6)
Pain Threshold Measurement
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
Measured: June 2026- July 2026
Beck Anxiety Inventory (BAI)
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.
Measured: June 2026- July 2026
Beck Depression Inventory (BDI)
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.
Measured: June 2026- July 2026
Semmes-Weinstein Monofilament Test
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
Measured: June 2026- July 2026
Subjective Health Complaints Inventory
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.
Measured: June 2026-July 2026
Fagerström Test for Nicotine Dependence
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.
Measured: June 2026- July 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco SmokingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571941
- Sponsor's protocol ID
- 2026/3-6
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations. All data will be analyzed and reported in an aggregated and anonymized form to ensure participant protection.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Carbon Monoxide (CO) Levels on Pain Threshold, Sensory Function, Anxiety, Depression, and Subjective Health Complaints
- ClinicalTrials.gov ID
- NCT07571941
- Acronym / sponsor ID
- 2026/3-6
- Conditions
- Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco Smoking
- Keywords
- CO exposure, exhaled carbon monoxide, pain threshold, sensory function, smoking and CO, healthy adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 May 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include healthy adult participants aged 18-65 years with a history of regular smoking for at least the past 6 months. Participants will be free of respiratory, cardiovascular, neurological, and psychiatric diseases, and will not have any acute infection or recent surgery affecting respiratory muscles.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- -
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exhaled Carbon Monoxide (CO) Level
Time frame: June 2026- July 2026
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
6 secondary outcomes
Pain Threshold Measurement
Time frame: June 2026- July 2026
Beck Anxiety Inventory (BAI)
Time frame: June 2026- July 2026
Beck Depression Inventory (BDI)
Time frame: June 2026- July 2026
Semmes-Weinstein Monofilament Test
Time frame: June 2026- July 2026
Subjective Health Complaints Inventory
Time frame: June 2026-July 2026
Fagerström Test for Nicotine Dependence
Time frame: June 2026- July 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations. All data will be analyzed and reported in an aggregated and anonymized form to ensure participant protection.
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.
Betül Taşpınar, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco Smoking, run by Izmir Democracy University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Taşpınar, Professor (+90 506 680 44 26), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled Carbon Monoxide (CO) Level (time frame: June 2026- July 2026). 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 7 May 2026.