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Sleep Chatbot Intervention for Emerging Black/African American Adults

Primary Purpose

Sleep Deprivation, Insomnia, Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sleep chatbot
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Deprivation focused on measuring sleep health, cardiometabolic health, emerging adults

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sleep chatbot intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 9, 2023
Last Updated
July 13, 2023
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT05956886
Brief Title
Sleep Chatbot Intervention for Emerging Black/African American Adults
Official Title
Artificial Intelligence Sleep Chatbot in Emerging Black/African American Adults With Cardiometabolic Risk Factors: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Insomnia, Metabolic Syndrome
Keywords
sleep health, cardiometabolic health, emerging adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
This is a feasibility study aimed at developing a new intervention strategy.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sleep chatbot intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sleep chatbot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total sleep time
Description
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.
Time Frame
Change from Baseline total sleep time in the end of intervention and 4-week follow-up.
Title
Sleep efficiency
Description
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.
Time Frame
Change from Baseline sleep effficiency in the end of intervention and 4-week follow-up.
Title
Intra-individual variability in midsleep times
Description
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.
Time Frame
Change from baseline data of intra-individual variability in midsleep times in the end of intervention and 4-week follow-up.
Title
Insomnia Severity
Description
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.
Time Frame
Change from baseline score of Insomnia Severity Index in the end of intervention and 4-week follow-up.
Secondary Outcome Measure Information:
Title
Metabolic health
Description
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.
Time Frame
Change from baseline number of metabolic syndrome components in the end of intervention and 4-week follow-up.
Other Pre-specified Outcome Measures:
Title
Chronotype (Morningness or eveningness)
Description
A self-assessment questionnaire, Horne and Ostberg Morningness/Eveningness Questionnaire, will be used to determine morningness-eveningness in circadian rhythms---the degree to which respondents are active and alert at certain times of the day. The scale requires between 10 and 15 min for completion. The sum gives a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", and scores between 42-58 indicate "intermediate types".
Time Frame
Change from baseline score of Horne and Ostberg Morningness/Eveningness Questionnaire in the end of intervention and 4-week follow-up.
Title
Daytime sleepiness
Description
The Epworth Sleepiness Scale will be used to assess daytime sleepiness. The total score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher score suggests the higher that person's average sleep propensity in daily life, or 'daytime sleepiness'.
Time Frame
Change from baseline score of Epworth Sleepiness Scale in the end of intervention and 4-week follow-up.
Title
Sleep beliefs
Description
The Dysfunctional Beliefs and Attitudes about Sleep Scare (DBAS-16) is a 16-item self-report measure designed to evaluate a subset of those sleep-related cognition/beliefs (e.g., beliefs, attitudes, expectations, appraisals, attributions). For each item, a higher score suggests a greater dysfunctional belief about sleep. Items with scores > 5 are concerning.
Time Frame
Change from baseline scores of Dysfunctional Beliefs and Attitudes about Sleep Scare in the end of intervention and 4-week follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaopeng Ji, PhD
Phone
302-831-3086
Email
jixiaop@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaopeng Ji, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Sleep Chatbot Intervention for Emerging Black/African American Adults

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