Drinking, AlcoholNCT03658954
Multimodal Sleep Intervention Using Wearable Technology
A study testing Advice, Self-monitoring and Feedback in people with Drinking, Alcohol, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Drinking, Alcohol
- What is being tested?
- Advice, Self-monitoring and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Multimodal Sleep Intervention Using Wearable Technology to Reduce Heavy Drinking in Young Adults
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.
Read the 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 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.
- Conditions
- Drinking, Alcohol
- Being tested
- Advice, Self-monitoring, Feedback
- Keywords
- Sleep Disorders, Self-Management, Telemedicine, Health Education, Wearable Electronic Devices
- Medical subject headings
- Alcohol Drinking, Sleep Wake Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdviceBehavioural
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep health advice.
Self-monitoringBehavioural
Participants will complete daily smartphone-based sleep and alcohol diaries for two weeks.
FeedbackBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Advice | Active comparator | Participants receive only web-based sleep health advice Receives: Behavioral: Advice |
| Advice + Self-monitoring | Experimental | Participants receive web-based sleep health advice + sleep/alcohol smartphone diary self-monitoring Receives: 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 Receives: Behavioral: Advice; Behavioral: Self-monitoring; Behavioral: Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, week 4, week 8 and week 12
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start7 Dec 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drinking, AlcoholStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658954
- Sponsor's protocol ID
- 2000021048
- Other IDs
- R34AA026021
- Status last verified
- May 2025
- First submitted
- 31 Aug 2018
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40445615Griffith 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.
PubMed 39613828Fucito 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.
PubMed 33635276
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multimodal Sleep Intervention Using Wearable Technology to Reduce Heavy Drinking in Young Adults
- ClinicalTrials.gov ID
- NCT03658954
- Acronym / sponsor ID
- 2000021048
- Conditions
- Drinking, Alcohol
- Keywords
- Sleep Disorders, Self-Management, Telemedicine, Health Education, Wearable Electronic Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Advice | Active comparator | Behavioral: AdviceParticipants receive only web-based sleep health advice |
| Advice + Self-monitoring | Experimental | Behavioral: Advice, Behavioral: Self-monitoringParticipants receive web-based sleep health advice + sleep/alcohol smartphone diary self-monitoring |
| Advice + Self-monitoring + Feedback | Experimental | Behavioral: Advice, Behavioral: Self-monitoring, Behavioral: FeedbackParticipants receive web-based sleep health advice + sleep/alcohol smartphone diary self-monitoring + 2 sessions of sleep/alcohol wearable/diary data feedback \& tailored coaching |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdviceOnce per week for two weeks, participants will come to in-person visits to receive brief web-based sleep health advice. | Behavioural | Advice, Advice + Self-monitoring, Advice + Self-monitoring + Feedback |
| Self-monitoringParticipants will complete daily smartphone-based sleep and alcohol diaries for two weeks. | Behavioural | Advice + Self-monitoring, Advice + Self-monitoring + Feedback |
| FeedbackParticipants 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 | Behavioural | Advice + Self-monitoring + Feedback |
Primary outcome
Total Alcohol Drinks Consumed Over the 12wk Followup
Time frame: weeks 4 through 12
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.
3 secondary outcomes
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments
Time frame: 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
Time frame: Baseline, week 4, week 8 and week 12
End of Treatment Satisfaction Survey Score
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40445615Fucito 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.
- Derived from this study: PubMed 39613828Griffith 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.
- Derived from this study: PubMed 33635276Fucito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice, Self-monitoring and Feedback in people with Drinking, Alcohol, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Alcohol Drinks Consumed Over the 12wk Followup (time frame: weeks 4 through 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03658954, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.