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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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

+90 506 680 44 26

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.

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 groups in NCT07571941
Study groupRoleWhat they receive
Healthy Adults - CO ExposureThis 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted7 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

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)
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.

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.

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