NCT07571941

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

CO exposureexhaled carbon monoxidepain thresholdsensory functionsmoking and COhealthy adults

Outcome Measures

Primary Outcomes (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

    June 2026- July 2026

Secondary Outcomes (6)

  • Pain Threshold Measurement

    June 2026- July 2026

  • Beck Anxiety Inventory (BAI)

    June 2026- July 2026

  • Beck Depression Inventory (BDI)

    June 2026- July 2026

  • Semmes-Weinstein Monofilament Test

    June 2026- July 2026

  • Subjective Health Complaints Inventory

    June 2026-July 2026

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepressionTobacco SmokingSmoking

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorTobacco Use

Central Study Contacts

Betül Taşpınar, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.