Multimodal Sleep Intervention Using Wearable Technology

Drinking, Alcohol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658954
• Other study ID #: 2000021048
• Secondary ID: R34AA026021
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Drinking, Alcohol

Intervention

Behavioral:
• Advice
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
• Self-monitoring
Participants will complete daily web-based sleep and alcohol diaries for two weeks.
• 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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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