Multimodal Sleep Intervention Using Wearable Technology

Yale University

Status: Completed

Conditions: Drinking, Alcohol

Treatments: Behavioral: Self-monitoring; Behavioral: Feedback; Behavioral: Advice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03658954

R34AA026021 (U.S. NIH Grant/Contract)

2000021048

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts 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 smartphone 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

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 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;
6. current DSM-V substance use disorder (other than cannabis) or a positive urine drug screen for opiates, cocaine, barbiturates, benzodiazepines, amphetamines, or phencyclidine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Advice

Active Comparator group

Description:

Participants receive only web-based sleep health advice

Treatment:

Behavioral: Advice

Advice + Self-monitoring

Experimental group

Description:

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

Treatment:

Behavioral: Advice

Behavioral: Self-monitoring

Advice + Self-monitoring + Feedback

Experimental group

Description:

Participants receive web-based sleep health advice + sleep/alcohol smartphone diary self-monitoring + 2 sessions of sleep/alcohol wearable/diary data feedback \& tailored coaching

Treatment:

Behavioral: Advice

Behavioral: Feedback

Behavioral: Self-monitoring