What is the mechanism of action of this treatment?

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a common treatment for sleep deprivation that focuses on changing sleep habits and misconceptions about sleep. It includes techniques such as maintaining a regular sleep-wake schedule, avoiding electronic devices before bedtime, using the bed only for sleep, and employing relaxation techniques to reduce anxiety. These strategies help to recondition the mind and body to associate the bed with sleep, thereby improving sleep quality and duration. This is crucial for sleep deprivation patients as it addresses the root behavioral and cognitive issues contributing to their sleep problems, leading to more sustainable and long-term improvements in sleep health.

What side effects are associated with this type of intervention?

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is generally well-tolerated with minimal side effects. Some patients may experience temporary increases in anxiety or frustration as they adjust to new sleep habits and routines. Unlike pharmacological treatments, CBT-I does not carry risks of dependency or significant adverse effects. However, it requires active participation and commitment, which can be challenging for some individuals. Other treatments for sleep deprivation, such as light therapy, may cause headaches or eye strain, while pharmacological options like hypnotics can lead to dependency, daytime drowsiness, and other side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for sleep disorders, including pharmacological agents like tasimelteon for Non-24-Hour Sleep-Wake Disorder and modafinil for excessive daytime sleepiness associated with narcolepsy. While these drugs address specific sleep disorders, Cognitive-Behavioral Therapy for Insomnia (CBT-I) remains a cornerstone non-pharmacological treatment for insomnia and sleep deprivation. CBT-I has been shown to be effective in various populations, including cancer survivors, and is now being explored through innovative delivery methods such as AI-driven sleep chatbots to improve accessibility and adherence.

What other types of research exist?

Promising alternatives to AI Sleep Chatbot (CBT-I) for treating sleep deprivation in 2024 include: 1) Melatonin supplementation, which has shown efficacy in improving sleep in children with autism spectrum disorders. 2) Prolonged-release melatonin formulations, which have been effective for insomnia in children with neurodevelopmental disabilities. 3) Light therapy, which has been used to reduce fatigue and improve sleep quality in adolescents and young adults with cancer. 4) Graduated extinction techniques for treating infant sleep disturbances. 5) Systematic light exposure for treating cancer-related fatigue and sleep disturbances. These alternatives offer a range of pharmacologic and non-pharmacologic options that can be tailored to individual patient needs.

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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

No Placebo-Only Group

Summary

This trial tests an AI sleep chatbot that uses therapy techniques to help young Black/African American adults with poor sleep and metabolic issues. The chatbot offers personalized tips to improve sleep by changing bedtime habits and thoughts about sleep.

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.

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.

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 below

Select...

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline total sleep time in the end of intervention and 4-week follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity

Intra-individual variability in midsleep times

Sleep efficiency

+1 more

Secondary study objectives

Metabolic health

Other study objectives

Chronotype (Morningness or eveningness)

Daytime sleepiness

Sleep beliefs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a common treatment for sleep deprivation that focuses on changing sleep habits and misconceptions about sleep. It includes techniques such as maintaining a regular sleep-wake schedule, avoiding electronic devices before bedtime, using the bed only for sleep, and employing relaxation techniques to reduce anxiety. These strategies help to recondition the mind and body to associate the bed with sleep, thereby improving sleep quality and duration. This is crucial for sleep deprivation patients as it addresses the root behavioral and cognitive issues contributing to their sleep problems, leading to more sustainable and long-term improvements in sleep health.

The effect of robot interventions on sleep in adults: a systematic review and network meta-analysis.Cognitive behavioral treatment for insomnia is equally effective in insomnia patients with objective short and normal sleep duration.Mediators of cognitive-behavioral therapy for insomnia: a review of randomized controlled trials and secondary analysis studies.