Smoking, Tobacco
Conditions
Brief summary
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
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.
Interventions
DEVICECarbon Monoxide Breath Sensor System (COBSS)
Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.
DEVICEBedfont - Micro+™ Smokerlyzer®
Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.
Sponsors
UserWise, LLC
David Utley, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
All subjects experience device use compared to a control device (predicate).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices | 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. |
| Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | 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
| Measure | Time frame | Description |
|---|---|---|
| User Documentation Assessment With Questionnaire With Observer Ratings | 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. |
| Number of Participants Answering No for the Subjective Feedback With Questionnaire | 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. |
| Participant Assessment With Questionnaire Rating Scales | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18-49 Year Old Smokers Using COBSS 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
Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.
Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. | 39 |
| ≥50 Year Old Smokers Using COBSS 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
Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.
Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. | 31 |
| Total | 70 |
Baseline characteristics
| Characteristic | 18-49 Year Old Smokers Using COBSS | ≥50 Year Old Smokers Using COBSS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 30 Participants | 69 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) White | 16 Participants | 16 Participants | 32 Participants |
| Region of Enrollment United States | 39 participants | 31 participants | 70 participants |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 32 Participants |
| Sex: Female, Male Male | 21 Participants | 17 Participants | 38 Participants |
| smoke frequency 1 per day | 2 Participants | 0 Participants | 2 Participants |
| smoke frequency 2 - 7 per day | 21 Participants | 10 Participants | 31 Participants |
| smoke frequency 8 or more per day | 16 Participants | 21 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 31 | 0 / 70 |
| other Total, other adverse events | 0 / 39 | 0 / 31 | 0 / 70 |
| serious Total, serious adverse events | 0 / 39 | 0 / 31 | 0 / 70 |
Outcome results
Primary
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.
Time frame: 1 minute for each question; up to 90 minutes for study session
Population: Outcome measure data table is tally of participants who were 'Successful' in each use scenario.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | use the device - submit a breath sample | 37 Participants |
| All Participants | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | set up the device- Pair Breath Sensor | 34 Participants |
| All Participants | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | interpret results | 38 Participants |
| ≥50 Year Old Smokers Using COBSS | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | use the device - submit a breath sample | 29 Participants |
| ≥50 Year Old Smokers Using COBSS | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | set up the device- Pair Breath Sensor | 25 Participants |
| ≥50 Year Old Smokers Using COBSS | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | interpret results | 31 Participants |
| All Participants | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | set up the device- Pair Breath Sensor | 59 Participants |
| All Participants | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | interpret results | 69 Participants |
| All Participants | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | use the device - submit a breath sample | 66 Participants |
Primary
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.
Time frame: 1 minute
Population: The performance outcome was designed to evaluate all the participants together, thus the cohorts (arms/groups) were not evaluated separately for this outcome. The cohorts were used for the human factors and usability portion of the study, but are not applicable for this outcome.~The R value reported is the correlation coefficient between 70 paired CO measurement values taken with the COBSS and predicate devices, by the 70 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices | 0.9878 Correlation coefficient (R-value) |
Secondary
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.
Time frame: Up to 90 minutes
Population: Outcome measure data table is tally of participants answering No.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Were there any points during ... that you experienced difficulty or had concerns about the product?* | 30 Participants |
| All Participants | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Did you have any safety concerns regarding the product or labeling? | 35 Participants |
| All Participants | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Did you experience any moments of hesitation while using the product? | 33 Participants |
| ≥50 Year Old Smokers Using COBSS | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Did you experience any moments of hesitation while using the product? | 27 Participants |
| ≥50 Year Old Smokers Using COBSS | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Did you have any safety concerns regarding the product or labeling? | 26 Participants |
| ≥50 Year Old Smokers Using COBSS | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Were there any points during ... that you experienced difficulty or had concerns about the product?* | 23 Participants |
| All Participants | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Did you experience any moments of hesitation while using the product? | 60 Participants |
| All Participants | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Did you have any safety concerns regarding the product or labeling? | 61 Participants |
| All Participants | Number of Participants Answering No for the Subjective Feedback With Questionnaire | Were there any points during ... that you experienced difficulty or had concerns about the product?* | 53 Participants |
Secondary
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.
Time frame: Up to 90 minutes
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 3 - Neither easy nor difficult | 1 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 1 - Very difficult | 0 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 1 - Very difficult | 0 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 4 - Easy | 8 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 5 - Very Easy | 29 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 3 - Neither easy nor difficult | 3 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 5 - Very Easy | 26 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 2 - Difficult | 0 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 2 - Difficult | 0 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 4 - Easy | 9 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 2 - Difficult | 2 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 5 - Very Easy | 8 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 3 - Neither easy nor difficult | 2 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 2 - Difficult | 2 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 1 - Very difficult | 1 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 5 - Very Easy | 17 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 4 - Easy | 10 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 3 - Neither easy nor difficult | 2 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 1 - Very difficult | 0 Participants |
| ≥50 Year Old Smokers Using COBSS | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 4 - Easy | 18 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 5 - Very Easy | 34 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 3 - Neither easy nor difficult | 3 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 3 - Neither easy nor difficult | 5 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 2 - Difficult | 2 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 4 - Easy | 27 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 5 - Very Easy | 46 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 1 - Very difficult | 1 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 1 - Very difficult | 0 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How easy or difficult was it to understand and interpret the test results? | 4 - Easy | 18 Participants |
| All Participants | Participant Assessment With Questionnaire Rating Scales | How would you rate the ease or difficulty using the device and phone app? | 2 - Difficult | 2 Participants |
Secondary
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.
Time frame: Up to 90 minutes
Population: How clear or unclear were the User Manual Reference Card, and Quick Start Guide?
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 2 - Unclear | 0 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 3 - Neither Clear nor Unclear | 2 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 5 - Very Clear | 23 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 4 - Clear | 13 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 1 - Very Unclear | 0 Participants |
| ≥50 Year Old Smokers Using COBSS | User Documentation Assessment With Questionnaire With Observer Ratings | 3 - Neither Clear nor Unclear | 1 Participants |
| ≥50 Year Old Smokers Using COBSS | User Documentation Assessment With Questionnaire With Observer Ratings | 5 - Very Clear | 17 Participants |
| ≥50 Year Old Smokers Using COBSS | User Documentation Assessment With Questionnaire With Observer Ratings | 4 - Clear | 10 Participants |
| ≥50 Year Old Smokers Using COBSS | User Documentation Assessment With Questionnaire With Observer Ratings | 2 - Unclear | 2 Participants |
| ≥50 Year Old Smokers Using COBSS | User Documentation Assessment With Questionnaire With Observer Ratings | 1 - Very Unclear | 1 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 2 - Unclear | 2 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 5 - Very Clear | 40 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 3 - Neither Clear nor Unclear | 3 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 4 - Clear | 23 Participants |
| All Participants | User Documentation Assessment With Questionnaire With Observer Ratings | 1 - Very Unclear | 1 Participants |