Skip to main content
OpenTrials
Completed

NCT Number: NCT03658954

Multimodal Sleep Intervention Using Wearable Technology

This research study is examining three different components of a digital sleep intervention: web-based sleep health advice, sleep and alcohol smartphone diary self-monitoring, and personalized sleep and alcohol consumption feedback from wearables/diaries and tailored coaching. The study is designed to find out which of these components are most effective for reducing alcohol use and improving sleep health among young adults. The study has three parts: 1) an intake session; 2) a 2-week treatment phase; and 3) three follow-up visits over the next 10 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drinking, Alcohol Adherence Interventions Alcohol Drinking Behavior Drinking Behavior Health Behavior Health Education Medication Adherence Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

Targeting sleep concerns may be a novel strategy for reducing increased risk of alcohol use disorders in young adults. The current study will develop and test a multimodal digital intervention addressing sleep concerns in 120 heavy-drinking young adults. All participants will wear sleep and alcohol biosensors daily. Participants will be randomized to one of three interventions. The primary intervention (60 participants) will include web-based sleep health advice + sleep/alcohol smartphone diary self-monitoring + sleep/alcohol data wearable/diary feedback & tailored coaching. The comparison interventions will be compared to matched control conditions only including these components: (1) web-based sleep health advice (30 participants) or (2) web-based sleep health advice + sleep/alcohol smartphone diary self-monitoring (30 participants). The primary objective is to evaluate sleep intervention component feasibility, acceptability, and preliminary efficacy on alcohol and sleep outcomes to inform a large scale Stage II randomized trial comparing the final digital intervention against standard care for this population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-25 years of age;
  • report ≥ 3 heavy drinking occasions in the last 2 weeks (i.e., ≥5 drinks on 1 occasion for men; ≥4 for women);
  • report having concerns about their sleep;
  • willing/able to complete daily smartphone diaries and wear sleep and alcohol trackers;
  • report Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) scores indicative of risk of harm from drinking (i.e., ≥7 and ≥5 for men and women, respectively)
  • read and understand English;
  • have a smartphone

Exclusion criteria

  • history of a sleep disorder;
  • night or rotating shift work; travel beyond 2 time zones in month prior and/or planned travel beyond 2 time zones during study participation;
  • meet criteria for an alcohol use disorder in the past 12 months that is clinically severe defined by: a) a history of seizures, delirium, or hallucinations during alcohol withdrawal; b) report drinking to avoid withdrawal symptoms or have had prior treatment of alcohol withdrawal; c) have required medical treatment of alcohol withdrawal in the past 6 months;
  • currently enrolled in alcohol or sleep treatment;
  • exhibit current severe psychiatric illness (i.e., bipolar disorder, schizophrenia, major depression, panic disorder, organic mood or mental disorders, or suicide or violence risk) by history or psychological examination;
  • current DSM-V substance use disorder (other than cannabis) or a positive urine drug screen for opiates, cocaine, barbiturates, benzodiazepines, amphetamines, or phencyclidine.

Treatment and study plan

Advice

Behavioral

Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep health advice.

Self-monitoring

Behavioral

Participants will complete daily smartphone-based sleep and alcohol diaries for two weeks.

Feedback

Behavioral

Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Philips actiwatches and SCRAM ankle biosensors & smartphone diaries & tailored coaching with a health coach

Primary outcomes

  1. Total Alcohol Drinks Consumed Over the 12wk Followup

    Time frame: weeks 4 through 12

    This will be recorded using the Timeline Follow-back Interview, based on the U.S. Standard Drink Conversion Chart. Upon results entry, the outcome was updated to include the following: data are log-transformed total alcohol drinks consumed over time from Week 4 to Week 12 follow-up, controlling for baseline.

Secondary outcomes

  1. National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments

    Time frame: Baseline, week 4, week 8 and week 12

    This is a validated, reliable measure of perceived sleep quality/satisfaction and difficulty initiating/maintaining sleep. Upon results entry, the outcome was updated to reflect the following: Sleep Disturbance Score assessed at Week 4, 8 and 12, controlling for baseline. Scores represent standardized T scores with mean of 50 and a standard deviation of 10. Higher scores, 50 and above, equal greater sleep disturbance. Scores 60 and above are clinically significant. Presented is the least squares mean across assessments.

  2. National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments

    Time frame: Baseline, week 4, week 8 and week 12

    National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score assessed at Week 4, 8, and 12, controlling for baseline. Scores represent standardized T scores with mean of 50 and a standard deviation of 10. Higher scores, 50 and above, equal greater sleep-related impairment. Scores 60 and above are clinically significant. Presented is the least squares mean across assessments.

  3. End of Treatment Satisfaction Survey Score

    Time frame: 2 weeks

    In this survey, participants will rate their satisfaction associated with each intervention component using a 5-point Likert-type scale. Upon results entry, the outcome was corrected to reflect the following: the overall treatment satisfaction uses the mean of questions on a 5-point Likert-type scale from 0 to 4, with higher scores indicating greater satisfaction.

Other outcomes

  1. Stop-signal Reaction Time

    Time frame: 4 weeks

    The difference between the mean reaction time and the stop-signal delay on the stop-signal test. Upon results entry, the following was added: This outcome will be explored as a potential mechanism of sleep intervention condition effects on the primary outcome of total drinks consumed. If there is a significant effect of condition on total drinks, the analysis of stop signal reaction time will be conducted. Due to COVID-19, this assessment was stopped since it could not be administered virtually. Since there was no effect of condition on total drinks consumed, an analysis of this outcome as a potential mechanism was not undertaken. The following represents the number of participants in each condition had this assessment conducted prior to COVID.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Development of a Multimodal Sleep Intervention Using Wearable Technology to Reduce Heavy Drinking in Young Adults

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2018
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.