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Multimodal Sleep Intervention Using Wearable Technology

Primary Purpose

Drinking, Alcohol

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advice
Self-monitoring
Feedback
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drinking, Alcohol focused on measuring Sleep Disorders, Self-Management, Telemedicine, Health Education, Wearable Electronic Devices

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Advice

Advice + Self-monitoring

Advice + Self-monitoring + Feedback

Arm Description

Participants receive only web-based sleep hygiene advice

Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring

Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance score
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.
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. Total scores range from 26 to 130, with higher scores indicating greater satisfaction.
Stop-signal reaction time
The difference between the mean reaction time and the stop-signal delay on the stop-signal test

Full Information

First Posted
August 31, 2018
Last Updated
February 9, 2022
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03658954
Brief Title
Multimodal Sleep Intervention Using Wearable Technology
Official Title
Development of a Multimodal Sleep Intervention Using Wearable Technology to Reduce Heavy Drinking in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking, Alcohol
Keywords
Sleep Disorders, Self-Management, Telemedicine, Health Education, Wearable Electronic Devices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advice
Arm Type
Active Comparator
Arm Description
Participants receive only web-based sleep hygiene advice
Arm Title
Advice + Self-monitoring
Arm Type
Experimental
Arm Description
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Arm Title
Advice + Self-monitoring + Feedback
Arm Type
Experimental
Arm Description
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Intervention Type
Behavioral
Intervention Name(s)
Advice
Intervention Description
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring
Intervention Description
Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Intervention Type
Behavioral
Intervention Name(s)
Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total alcohol drinks consumed over the 12wk followup
Description
This will be recorded using the Timeline Follow-back Interview, based on the U.S. Standard Drink Conversion Chart.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance score
Description
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.
Time Frame
12 weeks
Title
End of treatment satisfaction survey score
Description
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.
Time Frame
2 weeks
Title
Stop-signal reaction time
Description
The difference between the mean reaction time and the stop-signal delay on the stop-signal test
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 sleep 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 that can be used to sync tracker data. An estimated 86% of young adults own 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 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; current DSM-V substance use disorder or a positive urine drug screen for opiates, cocaine, barbiturates, benzodiazepines, amphetamines, or phencyclidine.
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33635276
Citation
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.
Results Reference
derived

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Multimodal Sleep Intervention Using Wearable Technology

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