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Completed

NCT Number: NCT03148613

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

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)

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Key information

Conditions

Smoking, Tobacco Behavior Smoking Tobacco Smoking Tobacco Use

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carrot Sense

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon Monoxide Breath Sensor System (COBSS)

Device

Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.

Bedfont - Micro+™ Smokerlyzer®

Device

Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.

Primary outcomes

  1. Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices

    Time frame: 1 minute

    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.

  2. Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings

    Time frame: 1 minute for each question; up to 90 minutes for study session

    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.

Secondary outcomes

  1. User Documentation Assessment With Questionnaire With Observer Ratings

    Time frame: Up to 90 minutes

    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.

  2. Number of Participants Answering "No" for the Subjective Feedback With Questionnaire

    Time frame: Up to 90 minutes

    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.

  3. Participant Assessment With Questionnaire Rating Scales

    Time frame: Up to 90 minutes

    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.

Sponsors and collaborators

Lead sponsor

David Utley, MD

Industry

Collaborators

  • UserWise, LLC

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 11, 2017
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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