Multimodal Sleep Intervention Using Wearable Technology

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT03658954
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
122
1
3
36.8
3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Advice
  • Behavioral: Self-monitoring
  • Behavioral: Feedback
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Random assignment to one of three groups in 2:1:1 ratio, each group receiving some variation on 2-week intervention. Measurements taken at baseline, 4 weeks, 8 weeks, 12 weeks.Random assignment to one of three groups in 2:1:1 ratio, each group receiving some variation on 2-week intervention. Measurements taken at baseline, 4 weeks, 8 weeks, 12 weeks.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of a Multimodal Sleep Intervention Using Wearable Technology to Reduce Heavy Drinking in Young Adults
Actual Study Start Date :
Dec 7, 2018
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Total alcohol drinks consumed over the 12wk followup [12 weeks]

    This will be recorded using the Timeline Follow-back Interview, based on the U.S. Standard Drink Conversion Chart.

Secondary Outcome Measures

  1. National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance score [12 weeks]

    This is a validated, reliable measure of perceived sleep quality/satisfaction and difficulty initiating/maintaining sleep. Scores range from 8 to 40, with lower scores indicating greater sleep disturbance.

  2. End of treatment satisfaction survey score [2 weeks]

    In this survey, participants will rate their satisfaction associated with each intervention component using a 5-point Likert-type scale. Total scores range from 26 to 130, with higher scores indicating greater satisfaction.

  3. Stop-signal reaction time [4 weeks]

    The difference between the mean reaction time and the stop-signal delay on the stop-signal test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States 06511

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT03658954
Other Study ID Numbers:
  • 2000021048
  • R34AA026021
First Posted:
Sep 6, 2018
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022