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Behavioural Intervention
AI-Powered Device for Chronic Insomnia in Cancer Survivors
N/A
Recruiting
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing an AI-powered device to help young adult cancer survivors with chronic sleep disorders using cognitive behavioral therapy. #CBTI #VAVA #SleepDisorders
Who is the study for?
This trial is for young adult cancer survivors aged 18-29 who suffer from chronic insomnia. Participants must have a history of any type or stage of cancer and an internet router at home. They should be experiencing less sleep than recommended for their age over the past 3 months. Those with acute medical/psychiatric disorders, developmental disorders, or a life expectancy under 12 months cannot join.
What is being tested?
The study is testing the VAVA prototype, a voice-activated virtual assistant designed to deliver Cognitive Behavioral Therapy for Insomnia (CBT-I). The goal is to see if this device can help improve sleep among young adults who survived cancer and are struggling with chronic sleep issues.
What are the potential side effects?
Since the intervention involves using a virtual assistant device to provide therapy, there are no direct physical side effects expected from participating in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Feasibility of device use
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: Intervention armExperimental Treatment1 Intervention
Participants (N=15) will will be provided with the VAVA prototype along with installation instructions to embed the VAVA within their homes. We provide them with a smart speaker running our intervention, a smart lamp, and a new router. They will be asked to trial the VAVA for a period of 2 weeks, a duration consistent with the primary stage of CBT-I treatment.
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Who is running the clinical trial?
Medstar Health Research InstituteLead Sponsor
195 Previous Clinical Trials
183,144 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than a year.You are between 18 and 29 years old.You have a disorder that you were born with or that developed as you grew up.You have had any type of cancer at any stage in the past.You have been consistently getting less sleep than what is recommended for your age by the National Sleep Foundation for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm
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.
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