Sleep Chatbot Intervention for Emerging Black/African American Adults

Study Overview
=================
Brief Summary
-----------------
Unhealthy sleep and cardiometabolic risk are two major public health concerns in emerging Black/African American (BAA) adults. Evidence-based sleep interventions such as cognitive-behavioral therapy for insomnia (CBT-I) are available but not aligned with the needs of this at-risk group. Innovative work on the development of an artificial intelligence sleep chatbot using CBT-I guidelines will provide scalable and efficient sleep interventions for emerging BAA adults.

Detailed Description
-----------------
Abnormal metabolic syndrome (MetS) components affect up to 40% of emerging adults (18-25 years), particularly Black/African Americans (BAA). MetS risk in early life tracks into adulthood and predicts cardiovascular diseases and type 2 diabetes mellitus later in life. Unhealthy sleep is a known modifiable factor for MetS components. However, the prevalence of unhealthy sleep (up to 60%) in emerging adults is alarming, potentially exacerbating downstream future cardiometabolic health. Cognitive-behavioral therapy for insomnia (CBT-I) is an evidence-based intervention for unhealthy sleep that improves both sleep quantity and quality. Compared with traditional in-person intervention paradigms, digital CBT-I has comparable efficacy with enhanced accessibility and affordability. However, current digital CBT-I based programs are unable to deliver tailored content and interactive services in a humanlike way, thus are unable to meet the needs of emerging BAA adults at risk for MetS. Building on prior work by the team, the investigators will leverage artificial intelligence (AI) technologies and refine an AI sleep chatbot using CBT-I guidelines and examine its feasibility and efficacy in a 4-week clinical trial in short-or-poor sleeping, emerging BAA adults with at least one MetS factor.

Official Title
-----------------
Artificial Intelligence Sleep Chatbot in Emerging Black/African American Adults With Cardiometabolic Risk Factors: a Feasibility Study

Conditions
-----------------
Sleep Deprivation, Insomnia, Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: sleep chatbot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female ages 18-25 years old elf-identified as Black/African Americans (BAA), self-report short sleep (<7 hours) or poor sleep [Insomnia severity index (ISI) >10] MetS factors: at least one of the MetS factors confirmed by fasting blood testing during the first lab visit (fasting blood glucose ≥110mg/dL, high-density lipoprotein ≤ 40 mg/dL for males and ≤ 50 mg/dL for females, triglycerides ≥150mg/dL, blood pressure ≥130/85mmHg, waist circumference≥40 inches for males, ≥35 inches for females) own a smartphone (iPhone or Android). Exclusion Criteria: self-report medical conditions [i.e., major depressive disorder [Patient Health Questionnaire-9 (PHQ-9) ≥10) diagnosed obstructive apnea] that may affect sleep regular use of medications with substantial impact on sleep and cardio-metabolic markers shift worker smoker alcohol abuse (Alcohol Use Disorders Identification Test--short form score ≥7 for males and ≥5 for females) self-report pregnancy/lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Using the pretest-posttest design, the investigators will test the efficacy of the 4-week sleep chatbot intervention on improving sleep health (primary) and metabolic syndrome factors (exploratory).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sleep chatbot intervention<br>Using CBT-I principles, participants will receive a four-week intervention delivered through a chatbot. The self-administered intervention is comprised of personalized behavioral prescriptions based on stimulus control principles and sleep schedule modification goals using sleep efficiency (SE) criteria. Participants are allowed to self-adjust expectations and make realistic decisions on sleep schedules. Other CBT-I components will be used as on-demand content. The chatbot will facilitate sleep goal setting with the participant, communicate weekly behavioral prescription and CBT-I educational modules, collect sleep diary and provide adaptive feedback and reactive services (e.g. Q&A conversations) 24/7. | Behavioral: sleep chatbot<br>* Personalized intervention algorithms will be developed based on CBT-I guidelines, focus group data, individual sleep baseline information and self-reported prioritized sleep goals. The CBT-I intervention will focus on principles of sleep restriction and stimulus control, with other CBT-I components used as on-demand content. The sleep chatbot system will facilitate sleep goal-setting with the participant and communicate weekly behavioral prescriptions and educational modules. After baseline data collection, the research coordinator will provide intervention orientation and set up the first-week sleep modification goal during the in-person/Zoom meeting. Sleep modification goals in the remaining weeks will be developed through the participant-chatbot interaction. The Chatbot system will send sleep-related information and behavioral reminders/feedback based on the interactive conversation with participants. Participants will also complete a sleep diary prompted by a chatbot.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time | The total amount of sleep time (hours) will be estimated each night for seven consecutive days using a wrist-worn ActiGraph GT9X Link. The average sleep time over a week will be used in data analysis. | Change from Baseline total sleep time in the end of intervention and 4-week follow-up. | 
| Sleep efficiency | Sleep efficiency (percentage of time spent asleep while in bed) will be estimated each night for seven consecutive days using a wrist-worn ActiGraph GT9X Link. The average sleep efficiency over a week will be used in data analysis. This variable indicates sleep quality. | Change from Baseline sleep effficiency in the end of intervention and 4-week follow-up. | 
| Intra-individual variability in midsleep times | Sleep time and awakening time will be estimated for seven consecutive days using a wrist-worn ActiGraph GT9X Link. Mid-sleep time each night refers to the mid-point between sleep time and awakening time. Intra-individual variability in midsleep times will be calculated as the standard deviation of the mid-sleep time over a week for each participant. This variable reflects the regularity of sleep, with higher values showing greater irregularity. | Change from baseline data of intra-individual variability in midsleep times in the end of intervention and 4-week follow-up. | 
| Insomnia Severity | The Insomnia Severity Index is composed of 7 items measuring insomnia-related sleep disturbance. and daytime dysfunction. The seven answers are added up to get a total score (0-28), with higher scores indicating severer insomnia. | Change from baseline score of Insomnia Severity Index in the end of intervention and 4-week follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic health | The total number of metabolic syndrome components, including high waist circumference, high blood pressure, high fasting triglycerides and glucose, and low HDL, will be calculated to indicate metabolic health (higher value, worse metabolic health). A point-of-care test will provide the fasting glucose and cholesterol panel. | Change from baseline number of metabolic syndrome components in the end of intervention and 4-week follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep health, cardiometabolic health, emerging adults