A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults

Heavy Drinking Clinical Trial

Official title:

A Photoplethysmography Sensor-based Personalized Feedback Intervention for Heavy-drinking Young Adults Targeting Heart Rate Variability, Resting Heart Rate, and Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090995
• Other study ID #: 2000030417
• Secondary ID: 1R21AA028886-01A
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.

Description:

Proposed is a study to conduct the first controlled test of a feedback intervention targeting heart rate variability, resting heart rate, and sleep for heavy-drinking young adults (N=60; ages 18-25) and will leverage the capabilities of a consumer-marketed PPG sensor/mobile app. This study will evaluate the feasibility, acceptability, and preliminary efficacy of this intervention for promoting improvements in drinking, sleep, and health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 18-25 years of age

• Report = 4 heavy drinking occasions in the past 28 days

• Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm

• English Speaking

• Have a personal smartphone

Exclusion Criteria:

• Sleep Disorder History

• Night/ Rotating work shift

• Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation

• Clinically severe AUD in past 12 months

• Currently enrolled in alcohol or sleep treatment

• Current, severe psychiatric illness

• Current DSM-V substance use disorder

• Positive urine drug screen for a substance other than marijuana

Related Conditions & MeSH terms

• Harmful; Use, Alcohol
• Heavy Drinking

Intervention

Behavioral:
• Behavioral Self-Management and Feedback
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.
• Behavioral Self-Management
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

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* Note: There are 78 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total drinks consumed	Total drinks consumed will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this tool is dependent upon the amount of drinks consumed by the subject. Higher scores indicate more alcohol consumption for the given month.	10 weeks
Secondary	Drinks per drinking day	Total drinks per drinking day will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by the amount of self-reported alcohol consumption that occurred each day. A heavy drinking day for a man would be =5 drinks per sitting and for a women it would be =4 drinks per sitting.	10 weeks
Secondary	Percent heavy drinking days	Percent of heavy drinking days will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by the amount of heavy drinking days that occurred in the given month, for a man this would be =5 drinks per sitting and for a women it would be =4 drinks per sitting. A higher percentage in this category would indicate that there were more heavy drinking days for the subject this month.	10 weeks
Secondary	Self-reported abstinent days	Self-reported abstinent days will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by how many days a subject abstains from drinking. A higher score in this area would indicate less drinking days for the subject this month.	10 weeks
Secondary	Alcohol-related consequences	Alcohol related positive consequences will be measured using the PROMIS Alcohol- negative consequences assessment and the PROMIS Alcohol- positive consequences assessment. The negative consequences assessment has 31 questions and the positive consequences assessment has 20 questions. The range for this standardized measure is 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more alcohol-related consequences.	10 weeks
Secondary	Sleep quality	Sleep quality will be measured using the PROMIS Sleep- Related Impairment and Sleep Disturbance assessments. The sleep disturbance assessment has 27 questions and sleep related impairment assessment has 16 questions. The range for this standardized measure is 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences worse sleep quality.	10 weeks
Secondary	Sleep-related impairment	Sleep-related impairment will be measured using the PROMIS Sleep- Related Impairment and Sleep Disturbance assessments. The sleep disturbance assessment has 27 questions and the sleep-related impairment assessment has 16 questions. The range for this standardized measure is 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more sleep-related impairments.	10 weeks
Secondary	Sleep Duration	Sleep duration will be measured using data from the PPG device.This tool will measure how long a subject slept each night. Ideally, 7-9 hours of sleep should be obtained per night by young adults and this measure will allow subjects to see if they fall above or below the ideal.	6 weeks
Secondary	Heart Rate Variability (HRV)	Heart rate variability (HRV) will be measured using the PPG Device's HRV daily data. This tool monitors subjects heart rate, HRV can range from person to person, but typically higher HRV would indicate better cardiovascular health.	6 weeks
Secondary	Resting Heart Rate (RHR)	Resting Heart Rate (RHR) will be measured using the PPG Device's RHR daily data. This tool monitors subjects heart rate, RHR can vary anywhere between 40-100 beats per minute. Lower RHR would indicate better cardiovascular health.	6 weeks