Using Smartwatches to Monitor Smoking in Real-life Situations

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

21 years - 120 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Background: It is important to quickly identify when people are at risk of smoking. Most current methods rely on people reporting when they smoke or what makes them want to smoke. But this can be hard for people to do and may not always be accurate. Other methods use special gadgets to identify smoking movements, but these may not always work well in real life. We want to see if we can use devices available on the market such as smartwatches to identify signs in the body and hand movements that might indicate when someone is about to smoke, is currently smoking, or has just smoked.

Objective: To record body signs and hand movements before, during, and after smoking in real-life and in a lab to see how they change when someone is craving cigarettes, while a person is smoking, and after a person has smoked.

Eligibility: People who are 21 years or older and smoke, have no college degree or be currently enrolled in college, and are low-income earners. To participate in the study, participants have to pass a breath test that shows they smoke cigarettes and, for women, a urine test to show that they are not currently pregnant.

Design: Participants will complete an eligibility survey to see if they qualify to be in the study. If they qualify, they will answer a brief baseline survey that includes questions about themselves, their health, and their smoking behavior.

Participants will get a smartwatch to wear for 3 days at home, log each time they are about to smoke and have finished smoking, and answer a 5-question health survey via the app. They will get instructions on how to set up and wear the smartwatch. They will download a mobile application on their phone. The app will collect data from the smartwatch.

Participants will then come to the lab but will be asked not to smoke or drink alcohol for at least 12 hours. They will have to take a breath test to show they have not smoked or had alcohol. They will also give a blood sample. In the lab, they will sit in a room where they will be hooked to devices that monitor their vitals such as heart rate and blood pressure for one hour. They will also wear a smartwatch on each hand. While they are in the smoking room, they will go through 3 different phases: (a) pre-smoking where they will be asked to stay seated for about 25 minutes, (b) smoking where they will be asked to smoke as many cigarettes of their choice as they want for about 10 to 15 minutes, (c) post-smoking where they will be asked to stay seated, not smoking, for about 25 minutes. They will answer a brief 10-minute health survey before and after the session.

Participation will last for 3 days of home monitoring and 2 visits to the research clinic that last about 2 hours.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:

We will recruit up to 30 non-treatment seeking participants with low socioeconomic status who smoke. We will strive to have representation across racial and ethnic groups and biological sex. At least half of the participants must earn at or below 200% of the federal poverty guideline for 2024 corresponding to number of people in their household (US Department of Health and Human Services).

To be included in the study, participants must:

• be 21 years or older in compliance with Tobacco 21 laws
• have no college degree or be currently enrolled in college
• have smoked 100 cigarettes in their lifetime and 5+ cigarettes per day in the past year to establish daily smoking status
• willing to abstain from smoking for \>=12 hours prior to the lab visit verifiable by a CO reading that is below 10 ppm and retrospectively by minimal nicotine in blood sample
• willing to abstain from using any nicotine products or devices for \>=12 hours prior to the lab visit
• willing to abstain from alcohol use for \>=12 hours prior to the lab session verifiable by breath alcohol concentration (BrAC = 0.000)
• willing to adhere to all study procedures including agreeing to a blood draw and bringing \>=1cigarette for use during the study visit
• have a smartphone compatible with wearable device requirements for Bluetooth and operating system (iphone iOS 14 and higher, Android 9.0 and higher) and willing to download the study apps onto their phone
• speak English
• and willing and able to provide informed consent.

EXCLUSION CRITERIA:

Participants will be excluded if they:

• are not abstinent before the lab session through biochemical verification after two attempts
• have sought treatment for tobacco/nicotine use in the past 2 months (e.g., on pharmacotherapy for smoking cessation, enrolled in smoking cessation support programs or interventions)
• have past 3-month pulmonary or cardiovascular event, or those who have been hospitalized or visited the emergency room for seizure, stroke, or new heart problems,
• are pregnant or breastfeeding
• and are unable or unwilling to provide informed consent.

Vulnerable populations will not be enrolled in the study (i.e., adults unable to consent, individuals who are not yet adults, pregnant women, prisoners).

Study population

The study population will comprise individuals aged 21 years or older who currently smoke cigarettes. Participants must have completed a high school education or possess a lower level of academic achievement, and they should be classified as low-income earners. To be eligible for participation in the study, individuals will need to successfully pass a breath test that confirms their smoking status. Furthermore, female participants will be required to undergo a urine test to verify that they are not currently pregnant, ensuring the study's safety and ethical standards. This rigorous participant selection process is designed to ensure a focused and relevant study group that aligns with the research objectives.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Study start

Nov 15, 2026 Estimated

Primary completion

Apr 30, 2027 Estimated

Study completion

Mar 20, 2028 Estimated

First posted

Jul 16, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.