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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pivot Breath Sensor Human Factors and Usability Study

NCT03835260

Smoking Cessation Smoking, Tobacco

COMPLETED NA

Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months

NCT03295643

Smoking Cessation

COMPLETED NA

Smartphone Based Smoking Cessation Intervention

NCT03740490

Smoking Cessation

COMPLETED PHASE2/PHASE3

Proactive Health Intervention for Tobacco Users (Get PHIT)

NCT00169260

Smoking

COMPLETED PHASE2/PHASE3

Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology

NCT04172623

Tobacco Use Cessation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Reduction Smoking Behaviors Smoking, Tobacco Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pivot Breath Sensor (user group)

Self-reported daily smokers of 10 or more cigarettes per day

Group Type OTHER

Pivot Breath Sensor

Intervention Type DEVICE

The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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