Cognitive Behavioral Therapy for Insomnia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Cognitive Behavioral Therapy for Insomnia (CBT-I) combined with smart technology, such as wearable devices and AI, can better address insomnia in older adults living independently. Participants will use devices and apps to track their sleep and receive personalized guidance through videos and environmental cues like smart lights and sounds. The trial will compare this method, specifically the CBT-I-IoT-AI approach, to other treatments, including standard digital CBT-I (such as SleepEZ CBTi) and sleep hygiene education (like Sleep Hygiene IoT), to identify which is most effective at improving sleep quality. Individuals who regularly experience trouble sleeping at least three nights a week, resulting in daytime issues like fatigue or poor focus, might be a good fit. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative insomnia solutions.
Will I have to stop taking my current medications?
You can continue taking your current sleep-related medications as long as they are directed by your physician. However, you should not start any new treatments for sleep issues during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that digital and AI-enhanced Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and well-tolerated. Studies have found that this method can significantly improve sleep quality and increase patient satisfaction. No major reports of negative effects have emerged, indicating its safety.
The SleepEZ CBT-I solution has been widely used, with over 90,000 people trying it. It has proven as effective as sleep medication but without the side effects. This digital therapy is safe and helps maintain better sleep patterns over time.
Both treatments are based on well-established CBT-I methods, which have been safely used for a long time. This trial is in Phase 2, indicating that earlier studies showed some safety, but researchers are still carefully evaluating its effectiveness and any potential risks.12345Why are researchers excited about this trial's treatments?
Unlike traditional insomnia treatments that primarily involve medication or standard Cognitive Behavioral Therapy for Insomnia (CBT-I), the CBT-I-IoT-AI treatment is unique because it integrates Internet of Things (IoT) technology and artificial intelligence for a highly personalized experience. This treatment uses smart devices to provide real-time feedback and environmental adjustments, like smart lights and sounds, to create an optimal sleep environment. Additionally, daily animated videos are customized to address the specific challenges each user faces, making the therapy more tailored and potentially more effective. Researchers are excited because this approach could enhance sleep routines more dynamically and effectively than existing methods.
What evidence suggests that this trial's treatments could be effective for insomnia?
Research has shown that digital Cognitive Behavioral Therapy for Insomnia (CBT-I) can greatly improve sleep quality and reduce insomnia symptoms. In this trial, participants may be randomized to receive CBT-I with AI and smart devices, which studies have shown to improve sleep patterns, enhance adherence to the program, and increase overall satisfaction. Alternatively, participants might receive the SleepEZ program, a digital CBT-I solution widely used and proven to effectively improve insomnia symptoms, sleep quality, and daytime alertness. These findings suggest that both AI-enhanced CBT-I and SleepEZ effectively treat insomnia symptoms.34567
Who Is on the Research Team?
Daniel Taylor, PhD
Principal Investigator
University of Arizona
Are You a Good Fit for This Trial?
This trial is for older, healthy adults living independently who have trouble sleeping. Participants should be experiencing symptoms of insomnia but not have other major health issues that could affect their sleep or cognitive function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline assessments including cognitive tests and sleep metrics
Treatment
Participants receive the assigned intervention (CBT-I + IoT + AI, Sleep Hygiene + IoT, or Sleep-EZ CBT-I) for insomnia treatment
Post-Intervention Assessment
Participants complete post-intervention assessments including cognitive tests and sleep metrics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CBT-I-IoT-AI
- SleepEZ CBTi
- Sleep Hygiene IoT
Trial Overview
The study tests a high-tech version of Cognitive Behavioral Therapy for Insomnia (CBT-I) using smart devices and AI to see if it improves sleep better than standard CBT-I (SleepEZ) or just learning about good sleep habits. It measures how well participants sleep, their mental sharpness, and if they stick with the therapy.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this study arm will experience an attempted enhancement of standard video based digital CBT-I, that is facilitated with electronic device-based interventions (Internet of Things) and artificial intelligence (AI) customizations of content. Noninvasive ambulatory worn + bedside devices deliver real-time feedback of objective data to the participant on an application interface and this data is used to customize the software and promote healthy sleep routines. In addition, daily animated videos are customized to the users' challenges. Subjective data collected using the application are available live to the participant, when appropriate. Environmental cues and notifications are programmed into IoT devices to remind patients of their behavioral prescription and to create a living-space environment that is conducive to effective therapy. This will include smart lights and sounds that cue the participant.
Participants randomized to this study arm will experience sleep hygiene education and training, a component of CBT-I, which will also occur within the SleepSpace software to ensure all participants receive the same software platform and adherence is tracked uniformly across solutions. Users will have access to a version of our electronic application that enables them to track sleep in a sleep diary, access the animated Sleep Hygiene content created in the same way as the videos in the CBTi-IoT-AI condition, and integrate with smart light bulbs and sounds to receive certain sound and light interventions.
Participants randomized to this study arm will experience standard digital-based CBT-I that is delivered via the Path to Better Sleep program called SleepEZ that was created by Veteran Affairs (VA). The program will be administered within the SleepSpace software, which will be used to track adherence and deliver sham interventions. Users will have access to a pared-down version of the SleepSpace electronic application that enables them to track sleep in a sleep diary, access the content found in SleepEZ, and integrate with smart light bulbs and sounds to receive certain sound and light interventions. For example, the lights will brighten during the users expected circadian dip.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Proactive Life Inc
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Citations
Internet-delivered cognitive behavioral therapy for insomnia
A meta-analysis by Robert Zachariae et al. confirmed that eCBT-I significantly improves insomnia severity, sleep efficiency, sleep quality, latency, and total ...
Effectiveness of Cognitive Behavioural Therapy for ...
Multi‐component CBT‐I includes Cognitive Therapy, Stimulus Control Therapy (SCT), Sleep Restriction Therapy (SRT), relaxation techniques and sleep hygiene.
The Effectiveness of Digital Cognitive Behavioral Therapy to ...
Conclusions: The results of this trial demonstrate the effectiveness of digital CBT-I (SleepioRx) for treating insomnia, with gains sustained at ...
Digital and AI-Enhanced Cognitive Behavioral Therapy for ...
Results: The findings suggest that digital and AI-enhanced CBT significantly improves sleep parameters, patient adherence, satisfaction, and the personalization ...
Study Details | NCT07316153 | Deep Sleep in Older Adults
These active controls will help determine whether CBT-I +IoT+AI is effective at treating insomnia based on the Insomnia Severity Index (ISI) ( ...
Innovative Digital Cognitive Behavioral Treatment for ...
The program was constructed based on validated CBT-i theory and practice, incorporating the latest scientific data on CBT for insomnia. It was ...
Efficacy of Digital Cognitive Behavioral Therapy for ...
The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia ...
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