N/A
N=120
Multimodal Sleep Intervention Using Wearable Technology
Drinking, Alcohol
Bottom Line
View on ClinicalTrials.gov: NCT03658954 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Total Alcohol Drinks Consumed Over the 12wk Followup — 3.07; 2.95; 2.96 log-transformed total alcohol drinks — p=0.75
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Advice (Behavioral); Self-monitoring (Behavioral); Feedback (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Alcohol Drinks Consumed Over the 12wk Followup |
3.07; 2.95; 2.96 | 0.75 |
| SECONDARY National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments |
51.39; 49.75; 49.46 | 0.05 |
| SECONDARY National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments |
57.80; 57.05; 54.89 | 0.02 sig |
| SECONDARY End of Treatment Satisfaction Survey Score |
3.45; 3.48; 3.60 | — |
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.
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 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
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 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.
Data sourced from ClinicalTrials.gov (NCT03658954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.