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Behavioral Intervention
Sleep Chatbot for Insomnia
N/A
Recruiting
Led By Xiaopeng Ji, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female ages 18-25 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline sleep efficiency in the end of intervention and 4-week follow-up.
Awards & highlights
Study Summary
This trial tests an AI chatbot to help Black/African American emerging adults with sleep and cardiometabolic risk, using cognitive-behavioral therapy for insomnia guidelines.
Who is the study for?
This trial is for Black/African American adults aged 18-25 with at least one metabolic syndrome factor and poor sleep, owning a smartphone. Excluded are those with certain medical conditions, shift workers, diagnosed sleep apnea, regular users of sleep-affecting meds, smokers, heavy alcohol users, or pregnant/lactating individuals.Check my eligibility
What is being tested?
The study tests an AI-powered sleep chatbot designed using cognitive-behavioral therapy guidelines to improve sleep in young Black/African American adults who may be at risk for heart and metabolic issues due to poor sleeping patterns.See study design
What are the potential side effects?
Since the intervention involves non-pharmaceutical technology (a chatbot), no direct physical side effects are expected from its use. However, there might be indirect effects on lifestyle or stress levels due to changes in sleeping habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 25 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline total sleep time in the end of intervention and 4-week follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline total sleep time in the end of intervention and 4-week follow-up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity
Intra-individual variability in midsleep times
Sleep efficiency
+1 moreSecondary outcome measures
Metabolic health
Other outcome measures
Chronotype (Morningness or eveningness)
Daytime sleepiness
Sleep beliefs
Trial Design
1Treatment groups
Experimental Treatment
Group I: sleep chatbot interventionExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of DelawareLead Sponsor
154 Previous Clinical Trials
25,181 Total Patients Enrolled
Xiaopeng Ji, PhDPrincipal InvestigatorUniversity of Delaware
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke cigarettes.Criterion: You identify yourself as Black or African American.You are pregnant or breastfeeding.I have been diagnosed with sleep apnea that blocks my breathing.I have at least one metabolic syndrome factor confirmed by a blood test.I am between 18 and 25 years old.I regularly take medication that affects my sleep or heart health.I have been diagnosed with major depression (PHQ-9 score of 10 or higher).You work in shifts, not regular daytime hours.You usually sleep for less than 7 hours or have trouble sleeping most nights.You have a high score on a test that shows you may have a problem with drinking too much alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: sleep chatbot intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current research study including adults older than 25?
"This medical trial only accepts patients between 18 and 25 years old. For those under the age of 18, there are 40 other trials available while 238 studies exist for people above 65."
Answered by AI
Would I qualify to join this medical experiment?
"To qualify for this trial, potential participants must have a history of sleep deprivation and be between the ages of 18-25. The study is looking to recruit approximately thirty individuals."
Answered by AI
Are there still opportunities to apply for the experiment?
"The clinical trial data hosted on clinicaltrials.gov states that this study is not presently looking to include any more patients, as the last update was made in July 13th 2023. Nonetheless, there are 357 other trials actively recruiting participants right now."
Answered by AI
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