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Pivot Breath Sensor Study

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ClinicalTrials.gov Identifier: NCT04133064
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Marler, MD, Carrot Sense

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 21, 2019
Last Update Posted Date October 21, 2019
Actual Study Start Date  ICMJE September 25, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Stage of Change [ Time Frame: 3 months ]
    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.
  • Confidence to Quit [ Time Frame: 3 months ]
    Assessment of participant's attitudes towards quitting by measuring Confidence 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
  • Difficulty to Quit [ Time Frame: 3 months ]
    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
  • Quit attempts [ Time Frame: 3 months ]
    Assess participant's smoking behavior by measuring Quit attempts. Participant will be asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking? Answer choice: Yes/No
  • Cigarettes Per Day (CPD) [ Time Frame: 3 months ]
    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.
  • Point Prevalence Abstinence (PPA) [ Time Frame: 3 months ]
    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 Data obtained via questionnaires completed by the participants.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Feedback on breath sensor setup, experience and use [ Time Frame: 3 months ]
    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.
  • Feeback on impact [ Time Frame: 3 months ]
    Gather participant feedback on impact of breath sensor: Participant will be asked:
    1. How has using the breath sensor affected your motivation to quit smoking?
    2. How has using the breath sensor affected the number of cigarettes you smoke per day?
    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
  • Feeback on commercialization [ Time Frame: 3 months ]
    Gather participant feedback on commercialization: Participant will be asked:
    1. Hypothetical: if it was commercially available, would you be interested in buying the Pivot Breath Sensor? Answer: Yes/No
    2. What is a reasonable price you would expect to pay for the Pivot Breath Sensor that you have been using (nearest dollar)?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pivot Breath Sensor Study
Official Title  ICMJE Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.
Brief 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.
Detailed Description

Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor):

  • Change in attitudes towards quitting smoking
  • Change in smoking behavior
  • Participant feedback
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Smoking Reduction
  • Smoking Behaviors
  • Smoking, Tobacco
  • Smoking Cessation
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Pivot Breath Sensor (user group)
Self-reported daily smokers of 10 or more cigarettes per day
Intervention: Device: Pivot Breath Sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2019)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kristine Wong 415-234-0952 kristine@carrot.co
Contact: Craig Fujii 6509064255 craig@carrot.co
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04133064
Other Study ID Numbers  ICMJE c-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennifer Marler, MD, Carrot Sense
Study Sponsor  ICMJE Jennifer Marler, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jen Marler Carrot Sense
PRS Account Carrot Sense
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP