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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA026021 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advice | Active Comparator | Participants receive only web-based sleep health advice |
|
| Advice + Self-monitoring | Experimental | Participants receive web-based sleep health advice + sleep/alcohol smartphone diary 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advice | Behavioral | Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep health advice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40445615 | Derived | 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. | |
| 39613828 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Advice | Participants receive only web-based sleep hygiene advice Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice. |
| FG001 | Advice + Self-monitoring | Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring 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 smartphone diaries for two weeks. |
| FG002 | Advice + Self-monitoring + Feedback | Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback 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 smartphone 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 Philips actigraphs and SCRAM blood-alcohol trackers and smartphone diary data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
120 randomized participants that began the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Advice | Participants receive only web-based sleep hygiene advice Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice. |
| BG001 | Advice + Self-monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat analysis | Posted | Least Squares Mean | Standard Error | log-transformed total alcohol drinks | weeks 4 through 12 |
|
Up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Advice | Participants receive only web-based sleep hygiene advice Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Fucito, PhD | Yale University School of Medicine | (203) 200-1470 | lisa.fucito@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2020 | Dec 20, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2020 | Dec 20, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D012893 | Sleep Wake Disorders |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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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.
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| Self-monitoring | Behavioral | Participants will complete daily smartphone-based sleep and alcohol diaries for two weeks. |
|
| 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 |
|
| 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. | 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. | 2 weeks |
| 4 weeks |
| 33635276 | 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. |
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
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.
| BG002 | Advice + Self-monitoring + Feedback | Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring 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. |
| OG002 | Advice + Self-monitoring + Feedback | Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback 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. |
|
|
|
| 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. | Intention to treat analysis | Posted | Least Squares Mean | Standard Error | T-score | 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. | Intention to treat analysis | Posted | Least Squares Mean | Standard Error | T-score | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Advice + Self-monitoring | Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring 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. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Advice + Self-monitoring + Feedback | Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback 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. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D005159 | Health Care Facilities Workforce and Services |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |