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Behavioural Intervention
Intervention group for Sleep
Phase 2 & 3
Waitlist Available
Led By Vijaya Gottumukkala, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing how a sleep enhancement intervention, which uses a wearable device to monitor vital signs, affects cancer patients' quality of life. The intervention may improve patients' quality of life by reducing interruptions at night during hospital stays.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of Life Questionnaires (EuroQol Group EQ-5D)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 Intervention
Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device.
Group II: Control groupExperimental Treatment1 Intervention
Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep enhancement intervention
2022
Completed Phase 3
~90
ViSi Mobile device
2022
Completed Phase 3
~90
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,149 Total Patients Enrolled
1 Trials studying Sleep
188 Patients Enrolled for Sleep
Vijaya Gottumukkala, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
59 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant, in jail, have a history of confusion or suicidal thoughts, have had a stroke that caused measurable damage to your brain, have cerebral palsy or seizures, or have been diagnosed with a primary brain tumor or metastases.If you are under hospice care or expected to be soon, you cannot participate in this study.Patients who use medication to help them sleep are allowed to participate in the study to see if the treatment can also benefit those with existing sleep problems.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Control group
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.
Are there any positions available for test subjects?
"This clinical trial, as stated on clinicaltrials.gov, is still recruiting patients. The original posting date was 8/31/2022 and there has been one update to the listing."
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