Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496477
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-11-09
Brief Title:
Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The participants are being asked to be in this clinical trial a type of research study because the participants are going to have a hematopoietic stem cell transplant HSCT in the near future Participants that get HSCTs often get depression andor suffer from depressive symptoms tiredness and sleep disturbances
Primary Objective
To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant
Secondary Objectives
To evaluate the temporal effect and magnitude of BL vs DL therapy on depression in pediatric patients undergoing HSCT
To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant
To evaluate the response of BL therapy versus DL on sleep quality
Exploratory Objectives
To compare incidence of positive delirium screenings between those receiving BL therapy versus DL
To evaluate participant and caregiver perceptions of the acceptability ease of use and risksbenefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews
Primary Objective
To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant
Secondary Objectives
To evaluate the temporal effect and magnitude of BL vs DL therapy on depression in pediatric patients undergoing HSCT
To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant
To evaluate the response of BL therapy versus DL on sleep quality
Exploratory Objectives
To compare incidence of positive delirium screenings between those receiving BL therapy versus DL
To evaluate participant and caregiver perceptions of the acceptability ease of use and risksbenefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews
Detailed Description:
If you decide to be in this study you will be asked to
Complete some surveys before the study begins
Take more surveys for about 4 weeks
Wear light therapy glasses for about 30 minutes each day for about 4 weeks
Wear a wrist monitor every day and night for the 1st and last week of the study to record your motion and sleeping habits
Keep a sleep diary where you will mark the times that you sleep while wearing the wrist monitor
Complete an optional interview at the end of the study
Complete some surveys before the study begins
Take more surveys for about 4 weeks
Wear light therapy glasses for about 30 minutes each day for about 4 weeks
Wear a wrist monitor every day and night for the 1st and last week of the study to record your motion and sleeping habits
Keep a sleep diary where you will mark the times that you sleep while wearing the wrist monitor
Complete an optional interview at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None