N/A
Completed N=234
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
Smoking Reduction · Smoking Behaviors · Smoking, Tobacco · Smoking Cessation
Source: ClinicalTrials.gov NCT04133064 ↗
Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Number of Participants With Different Stages of Change in Desire to Quit Smoking — 84; 118; 13 Participants
Summary
Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Different Stages of Change in Desire to Quit Smoking |
84; 118; 13 | — |
| PRIMARY Success to Quit (STQ) |
5 | — |
| PRIMARY Difficulty to Quit (DTQ) |
4.3 | — |
| PRIMARY Average Quit Attempts Made Since Using the Pivot Breath Sensor |
2.4 | — |
| PRIMARY Change in Cigarettes Per Day (CPD) From Baseline |
178; 25; 12 | — |
| PRIMARY Point Prevalence Abstinence (PPA) |
28; 28; 14; 14 | — |
| SECONDARY Feedback on Breath Sensor Setup, Experience and Use |
1; 9; 10; 42; 165; 0 | — |
| SECONDARY Feedback on Impact on Motivation to Quit Smoking |
171; 55; 0; 1 | — |
| SECONDARY Feedback on Impact on Number of Cigarettes Smoked Per Day |
2; 119; 105; 1 | — |
| SECONDARY Feedback on Commercialization |
153; 63 | — |
Eligibility Criteria
Inclusion Criteria
- 18-80 years of age
- Current daily cigarette smokers (at least 10 cigarettes per day)
- Resident of the United States
- Able to read and comprehend English
- Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 11 and above, or, Android 5.0 and above with operating system Android 5.0 and above)
- Willing to sign the Informed Consent Form
Exclusion Criteria
- Pregnancy
- Participation in a previous study sponsored by Carrot Inc
Data sourced from ClinicalTrials.gov (NCT04133064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.