Multimodal Sleep Intervention Using Wearable Technology

NCT03658954 | Completed Results

• 2 other identifiers: 2000021048R34AA026021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drinking, Alcohol

Keywords

Sleep Disorders; Self-Management; Telemedicine; Health Education; Wearable Electronic Devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- 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

  Baseline, week 4, week 8 and week 12

• End of Treatment Satisfaction Survey Score

  2 weeks

Other Outcomes (1)

• Stop-signal Reaction Time

  4 weeks

Study Arms (3)

Advice

ACTIVE COMPARATOR

Participants receive only web-based sleep health advice

Behavioral: Advice

Advice + Self-monitoring

EXPERIMENTAL

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

Behavioral: Advice; Behavioral: Self-monitoring

Advice + Self-monitoring + Feedback

EXPERIMENTAL

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

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

Interventions

Advice BEHAVIORAL

Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep health advice.

Advice; Advice + Self-monitoring; Advice + Self-monitoring + Feedback

Self-monitoring BEHAVIORAL

Participants will complete daily smartphone-based sleep and alcohol diaries for two weeks.

Advice + Self-monitoring; Advice + Self-monitoring + Feedback

Feedback BEHAVIORAL

Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Philips actiwatches and SCRAM ankle biosensors \& smartphone diaries \& tailored coaching with a health coach

Advice + Self-monitoring + Feedback

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 smartphone 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (3)

• Fucito LM, Ash GI, Wu R, Pittman B, Barnett NP, Li CR, Redeker NS, O'Malley SS, DeMartini KS. Wearable Intervention for Alcohol Use Risk and Sleep in Young Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513167. doi: 10.1001/jamanetworkopen.2025.13167.

  PMID: 40445615 DERIVED

• Griffith FJ, Ash GI, Augustine M, Latimer L, Verne N, Redeker NS, O'Malley SS, DeMartini KS, Fucito LM. Natural language processing in mixed-methods evaluation of a digital sleep-alcohol intervention for young adults. NPJ Digit Med. 2024 Nov 29;7(1):342. doi: 10.1038/s41746-024-01321-3.

  PMID: 39613828 DERIVED

• 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.

  PMID: 33635276 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Sleep Wake Disorders; Health Education

Interventions

Counseling; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Lisa Fucito, PhD
• Organization: Yale University School of Medicine

lisa.fucito@yale.edu

(203) 200-1470

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 6, 2018
• Study Start: December 7, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 7, 2025
• Results First Posted: November 13, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)