Trial Outcomes & Findings for Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study (NCT NCT04133064)

NCT ID: NCT04133064

Last Updated: 2022-11-09

Results Overview

Assessment of participant's desire to quit by measuring Stage of Change. The participant will be asked if they are serious about quitting smoking and they can select from the following options: * Yes, within the next 30 days * Yes, within the next 6 months * No, not thinking of quitting All data obtained via questionnaires completed by the participants. Throughout the course of the study, if the participant moves from "No, not thinking of quitting" to "yes, within the next 6 months" to "Yes, within the next 30 days" - that is a positive outcome for the participant. If they answered in the reverse, that would be a negative outcome for the participant. In short, becoming more ready to quit is a positive outcome, becoming less ready to quit is a less positive outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 234 participants
• Primary outcome timeframe: 3 months (12 weeks) compared to baseline
• Results posted on: 2022-11-09

Participant Flow

Participant milestones

Measure	Pivot Breath Sensor (User Group) Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Overall Study STARTED	234
Overall Study COMPLETED	215
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study

Baseline characteristics by cohort

Measure	Pivot Breath Sensor (User Group) n=234 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Age, Customized 18-29 years	37 Participants n=5 Participants
Age, Customized 30-60 years	185 Participants n=5 Participants
Age, Customized 61-80 years	12 Participants n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	209 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic, Latinx, or Spanish Origin	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	9 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska Native	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Middle Eastern or North African	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Some other race, ethnicity, or origin	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Prefer not to answer	0 Participants n=5 Participants
Region of Enrollment United States	234 participants n=5 Participants
Education Less than 8th grade	0 Participants n=5 Participants
Education Some high school	7 Participants n=5 Participants
Education High school/General educational development	50 Participants n=5 Participants
Education Some college	107 Participants n=5 Participants
Education Associate's (2-year) degree	37 Participants n=5 Participants
Education Bachelor's (4-year) degree	25 Participants n=5 Participants
Education Master's degree	7 Participants n=5 Participants
Education Professional or doctorate degree	1 Participants n=5 Participants
Employment Unemployed	11 Participants n=5 Participants
Employment Employed <20 hours/week	29 Participants n=5 Participants
Employment Employed ≥ 20 hours/week	194 Participants n=5 Participants
Years smoking	21.7 years STANDARD_DEVIATION 11.5 • n=5 Participants
Cigarettes per day (CPD)	20.3 cigarettes smoked per day STANDARD_DEVIATION 8 • n=5 Participants
Would you like to stop smoking? yes	217 Participants n=5 Participants
Would you like to stop smoking? no	17 Participants n=5 Participants
Motivation to Quit (Stage of Change) - Are you seriously thinking of quitting smoking? Yes, within the next 30 days	36 Participants n=5 Participants
Motivation to Quit (Stage of Change) - Are you seriously thinking of quitting smoking? Yes, within the next 6 months	180 Participants n=5 Participants
Motivation to Quit (Stage of Change) - Are you seriously thinking of quitting smoking? No, not thinking of quitting	18 Participants n=5 Participants
Readiness to Quit (RTQ)	5.6 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants
Success to quit (STQ)	3.3 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Difficulty to quit (DTQ)	2.8 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months (12 weeks) compared to baseline

Population: Participants that completed the 12-week questionnaire

Assessment of participant's desire to quit by measuring Stage of Change.

The participant will be asked if they are serious about quitting smoking and they can select from the following options:

• Yes, within the next 30 days
• Yes, within the next 6 months
• No, not thinking of quitting All data obtained via questionnaires completed by the participants. Throughout the course of the study, if the participant moves from "No, not thinking of quitting" to "yes, within the next 6 months" to "Yes, within the next 30 days" - that is a positive outcome for the participant. If they answered in the reverse, that would be a negative outcome for the participant. In short, becoming more ready to quit is a positive outcome, becoming less ready to quit is a less positive outcome.

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=215 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Number of Participants With Different Stages of Change in Desire to Quit Smoking Increased motivation to quit	84 Participants	—
Number of Participants With Different Stages of Change in Desire to Quit Smoking Unchanged motivation to quit	118 Participants	—
Number of Participants With Different Stages of Change in Desire to Quit Smoking Decreased motivation to quit	13 Participants	—

PRIMARY outcome

Timeframe: 3 months (12 weeks)

Population: Participants that completed the 12 week questionnaire

Assessment of participant's attitudes towards quitting by measuring Success to Quit.

The participant will be asked If you were to quit smoking right now, how successful would you be? Rating Scale: 1 = Not at all successful, 10 = Completely successful. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking.

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=215 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Success to Quit (STQ)	5 units on a scale Standard Deviation 3.1	—

PRIMARY outcome

Timeframe: 3 months (12 weeks)

Population: Participants that completed the 12 week questionnaire

Assessment of participant's attitudes towards quitting by measuring Perceived Difficulty to staying Quit.

Participant will be asked: If you were to quit smoking right now, how difficult do you think it would be to stay smoke free? Rating scale: 1 = Really hard to stay quit, 10 = Really easy to stay quit. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking, specifically lower perceived difficulty to quit.

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=215 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Difficulty to Quit (DTQ)	4.3 units on a scale Standard Deviation 3.0	—

PRIMARY outcome

Timeframe: 3 months (12 weeks)

Population: Participants that completed the 12 week questionnaire

Assess participant's smoking behavior by measuring Quit attempts. Participant were asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking?

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=215 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Average Quit Attempts Made Since Using the Pivot Breath Sensor	2.4 quit attempts made Standard Deviation 9.1	—

PRIMARY outcome

Timeframe: 3 months (12 weeks)

Population: Participants that completed the 12 week questionnaire

Assess participant's smoking behavior by measuring CPD. Participant will be asked to enter a number for: How many cigarettes do you now smoke per day, on average? Enter number value.

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=215 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Change in Cigarettes Per Day (CPD) From Baseline Reduced CPD from baseline	178 Participants	—
Change in Cigarettes Per Day (CPD) From Baseline No change in CPD from baseline	25 Participants	—
Change in Cigarettes Per Day (CPD) From Baseline Increased CPD from baseline	12 Participants	—

PRIMARY outcome

Timeframe: 3 months (12 weeks)

Population: Participants that completed the 12 week questionnaire

Assess participant's smoking behavior by measuring 7-Day and 30-Day PPA. Participant will be asked: In the last 7 days and 30 days have you smoked any cigarettes? Answer choice: Yes/No 7-Day PPA is defined as answering "No" to "In the last 7 days have you smoked any cigarettes?" 30-Day PPA is defined as answering "No" to "In the last 30 days have you smoked any cigarettes?" Data obtained via questionnaires completed by the participants.

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=234 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer n=215 Participants Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Point Prevalence Abstinence (PPA) 7-day PPA	28 Participants	28 Participants
Point Prevalence Abstinence (PPA) 30-day PPA	14 Participants	14 Participants

SECONDARY outcome

Timeframe: 1 week

Population: Participants that completed the 1 week questionnaire. For question 3: If you ever got an error on the breath sensor screen, how easy or difficult was it to understand the issue and correct it? Other category = "I set up my breath sensor but have not gotten an error on the breath sensor screen"

Gather participant feedback on breath sensor setup:

Participant is asked:

1. How would you rate the ease or difficulty of getting started with the breath sensor?

2. How would you rate the ease or difficulty of following the directions on the breath sensor screen?

3. If you ever got an error on the breath sensor screen, how easy or difficult was it to understand the issue and correct it?

Select one:

1. - Very difficult

2. - Difficult

3. - Neither easy nor difficult

4. - Easy

5. - Very Easy I did not set up my breath sensor All data obtained via questionnaires completed by the participants.

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=227 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of getting started with the breath sensor? · 1 - Very Difficult	1 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of getting started with the breath sensor? · 2 - Difficult	9 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of getting started with the breath sensor? · 3 - Neither easy nor difficult	10 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of getting started with the breath sensor? · 4 - Easy	42 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of getting started with the breath sensor? · 5 - Very easy	165 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of getting started with the breath sensor? · Other	0 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of following the directions on the breath sensor screen? · 1 - Very Difficult	1 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of following the directions on the breath sensor screen? · 2 - Difficult	0 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of following the directions on the breath sensor screen? · 3 - Neither easy nor difficult	7 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of following the directions on the breath sensor screen? · 4 - Easy	36 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of following the directions on the breath sensor screen? · 5 - Very easy	183 Participants	—
Feedback on Breath Sensor Setup, Experience and Use How would you rate the ease or difficulty of following the directions on the breath sensor screen? · Other	0 Participants	—
Feedback on Breath Sensor Setup, Experience and Use If you ever got an error ... how easy or difficult was it to understand the issue and correct it? · 1 - Very Difficult	0 Participants	—
Feedback on Breath Sensor Setup, Experience and Use If you ever got an error ... how easy or difficult was it to understand the issue and correct it? · 2 - Difficult	5 Participants	—
Feedback on Breath Sensor Setup, Experience and Use If you ever got an error ... how easy or difficult was it to understand the issue and correct it? · 3 - Neither easy nor difficult	8 Participants	—
Feedback on Breath Sensor Setup, Experience and Use If you ever got an error ... how easy or difficult was it to understand the issue and correct it? · 4 - Easy	37 Participants	—
Feedback on Breath Sensor Setup, Experience and Use If you ever got an error ... how easy or difficult was it to understand the issue and correct it? · 5 - Very easy	92 Participants	—
Feedback on Breath Sensor Setup, Experience and Use If you ever got an error ... how easy or difficult was it to understand the issue and correct it? · Other	85 Participants	—

SECONDARY outcome

Timeframe: 1 week

Population: Participants that completed the 1 week questionnaire

Gather participant feedback on impact of breath sensor:

Participant will be asked: How has using the breath sensor affected your motivation to quit smoking?

Select one:

• Using the breath sensor has increased my motivation to quit smoking
• Using the breath sensor has not affected my motivation to quit smoking
• Using the breath sensor has decreased my motivation to quit smoking
• I haven't used the breath sensor

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=227 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Feedback on Impact on Motivation to Quit Smoking Using the breath sensor has increased my motivation to quit smoking	171 Participants	—
Feedback on Impact on Motivation to Quit Smoking Using the breath sensor has not affected my motivation to quit smoking	55 Participants	—
Feedback on Impact on Motivation to Quit Smoking Using the breath sensor has decreased my motivation to quit smoking	0 Participants	—
Feedback on Impact on Motivation to Quit Smoking I haven't used the breath sensor	1 Participants	—

SECONDARY outcome

Timeframe: 1 week

Population: Participants that completed the 1 week questionnaire

Gather participant feedback on impact of breath sensor:

Participant will be asked: How has using the breath sensor affected the number of cigarettes you smoke per day?

Select one:

• Using the breath sensor has increased the number of cigarettes I smoke per day
• Using the breath sensor has not affected the number of cigarettes I smoke per day
• Using the breath sensor has decreased the number of cigarettes I smoke per day
• I haven't used the breath sensor

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=227 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Feedback on Impact on Number of Cigarettes Smoked Per Day Using the breath sensor has decreased the number of cigarettes I smoke per day	105 Participants	—
Feedback on Impact on Number of Cigarettes Smoked Per Day Using the breath sensor has increased the number of cigarettes I smoke per day	2 Participants	—
Feedback on Impact on Number of Cigarettes Smoked Per Day Using the breath sensor has not affected the number of cigarettes I smoke per day	119 Participants	—
Feedback on Impact on Number of Cigarettes Smoked Per Day I haven't used the breath sensor	1 Participants	—

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants that completed the 4 week questionnaire

Gather participant feedback on commercialization:

Participant will be asked: Hypothetical: if it was commercially available, would you be interested in buying the Pivot Breath Sensor? Answer: Yes/No

Outcome measures

Measure	Pivot Breath Sensor (User Group) n=216 Participants Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Pivot Breath Sensor (User Group) - Completer Participants that completed the 12 week questionnaire Self-reported daily smokers of 10 or more cigarettes per day Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Feedback on Commercialization yes	153 Participants	—
Feedback on Commercialization no	63 Participants	—

Adverse Events

Pivot Breath Sensor (User Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP of Clinical and Medical Affairs

Pivot Health Technologies Inc.

Phone: 415-757-7696

Email: marler@pivot.co

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place