Multimodal Sleep Intervention Using Wearable Technology

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

This research study is examining three different components of a mobile sleep intervention: web-based sleep hygiene advice, sleep and alcohol diary self-monitoring, and personalized sleep and alcohol consumption feedback. The study is designed to find out which of these components are most effective for mitigating alcohol use disorders and improving sleep quality 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.

Study Overview

• Status: Completed
• Conditions: Drinking, Alcohol
• Intervention / Treatment: Behavioral: Advice; Behavioral: Self-monitoring; Behavioral: Feedback

Detailed Description

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 mobile intervention addressing sleep concerns in 120 heavy-drinking young adults. All participants will wear sleep and alcohol trackers daily. Participants will be randomized to one of three interventions. The primary intervention (60 participants) will include web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback. The comparison interventions will be compared to matched control conditions only including these components: (1) web-based sleep hygiene advice (30 participants) or (2) web-based sleep hygiene advice + sleep/alcohol diary self-monitoring (30 participants). The primary objective is to evaluate sleep intervention component feasibility, acceptability, and preliminary efficacy on alcohol outcomes to inform a Stage II randomized trial comparing the final sleep intervention with a standard alcohol intervention.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18-25 years of age;
2. report ≥ 3 heavy drinking occasions in the last 2 weeks (i.e., ≥5 drinks on 1 occasion for men; ≥4 for women);
3. report having concerns about their sleep;
4. willing/able to complete daily sleep diaries and wear sleep and alcohol trackers;
5. 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)
6. read and understand English;
7. have a smartphone that can be used to sync tracker data. An estimated 86% of young adults own a smartphone.

Exclusion Criteria:

1. history of a sleep disorder;
2. night or rotating shift work; travel beyond 2 time zones in month prior and/or planned travel beyond 2 time zones during study participation;
3. 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;
4. currently enrolled in alcohol or sleep treatment;
5. exhibit current psychiatric illness (i.e., bipolar disorder, schizophrenia, major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or suicide or violence risk) by history or psychological examination;
6. current DSM-V substance use disorder or a positive urine drug screen for opiates, cocaine, barbiturates, benzodiazepines, amphetamines, or phencyclidine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Advice; Participants receive only web-based sleep hygiene advice	Behavioral: Advice; Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Experimental: Advice + Self-monitoring; Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring	Behavioral: Advice; Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.; Behavioral: Self-monitoring; Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Experimental: Advice + Self-monitoring + Feedback; Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback	Behavioral: Advice; Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.; Behavioral: Self-monitoring; Participants will complete daily web-based sleep and alcohol diaries for two weeks.; Behavioral: Feedback; Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Alcohol Drinks Consumed Over the 12wk Followup	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.	weeks 4 through 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments	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.	Baseline, week 4, week 8 and week 12
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments	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.	Baseline, week 4, week 8 and week 12
End of Treatment Satisfaction Survey Score	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.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stop-signal Reaction Time	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.	4 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

General Publications

• Fucito LM, Ash GI, DeMartini KS, Pittman B, Barnett NP, Li CR, Redeker NS, O'Malley SS. A Multimodal Mobile Sleep Intervention for Young Adults Engaged in Risky Drinking: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 26;10(2):e26557. doi: 10.2196/26557.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Self-Management; Health Education; Sleep Disorders; Wearable Electronic Devices
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 2000021048; R34AA026021 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No