Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit

Study Overview
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Brief Summary
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Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)

Detailed Description
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Performance: Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices. Assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the predicate CO breath sensor (Bedfont). Human Factors and Usability: Ensure that representative intended users are able to operate the COBSS independently. Validate appropriate mitigations of use related hazards identified in risk management documentation. Uncover previously unforeseen use errors. NOTES: The study design allows for the assessment of a performance endpoint and human factors endpoint in a single study. Each participant will complete the study in a single visit which will include the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes.

Official Title
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Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit

Conditions
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Smoking, Tobacco

Intervention / Treatment
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* Device: Carbon Monoxide Breath Sensor System (COBSS)
* Device: Bedfont - Micro+™ Smokerlyzer®


Participation Criteria
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Eligibility Criteria
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Subject who self-report smoking 2 or more cigarettes each day Inclusion Criteria: 18-80 years of age English speaking Owns and uses a smartphone Willing to sign the Informed Consent Form Exclusion Criteria: • Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All subjects experience device use compared to a control device (predicate).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 18-49 year old smokers using COBSS<br>Younger smokers - Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE: 18-49 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers | Device: Carbon Monoxide Breath Sensor System (COBSS)<br>* Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.<br>Device: Bedfont - Micro+™ Smokerlyzer®<br>* Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.<br>|
| Other: ≥50 year old smokers using COBSS<br>Older smokers- Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE:≥50 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers | Device: Carbon Monoxide Breath Sensor System (COBSS)<br>* Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.<br>Device: Bedfont - Micro+™ Smokerlyzer®<br>* Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices | CO concentrations in parts per million (ppm) in exhaled breath from subjects at a single visit will be assessed and reported in order to compare the CO measurements from COBSS to a control (predicate) device. The correlation will be reported as an R value. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes. COBSS breath sample will take approximately 1 minute. Breath sample with the control device will take approximately 1 minute. The breath samples will be collected within 5-10 minutes of each other. | 1 minute | 
| Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors. Outcome measure data table is tally of participants who were 'Successful' in each use scenario. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes. Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 90 minutes. | 1 minute for each question; up to 90 minutes for study session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Documentation Assessment With Questionnaire With Observer Ratings | Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide, reference card, and user manual. Observer ratings include 'Successful' and 'Unsuccessful'. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes. Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes. The 5-Point Likert Scale for Clarity has the following answer options: 5 - Very Clear; 4 - Clear; 3 - Neither Clear nor Unclear; 2 - Unclear; and 1 - Very Unclear. Higher values of this scale represent a better outcome, which is greater clarity/understanding. | Up to 90 minutes | 
| Number of Participants Answering No for the Subjective Feedback With Questionnaire | Subjective feedback focusing on any concerns (i.e. 'yes', 'no') on using device will be assessed at single visit. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes. *Row title truncated due to character limit. Actual question asked: Were there any points during this portion of the study that you experienced difficulty or had concerns about the product? Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes. | Up to 90 minutes | 
| Participant Assessment With Questionnaire Rating Scales | Participant will be asked to provide ratings on the following: How would you rate the ease or difficulty using the device and phone app? 5 - Very Clear; 4 - Clear; 3 - Neither Clear nor Unclear; 2 - Unclear; 1 - Very Unclear How easy or difficult was it to understand and interpret the test results? For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes. Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each. The Subjective feedback portion of the study session will last up to 5 minutes. | Up to 90 minutes |