Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
Study NCT ID:
NCT06310161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2024-01-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Light Therapy in End Stage Kidney Disease
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
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 goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment.
Detailed Description:
In a single site, 2-arm (Bright Light Therapy group; Dim Light Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Bright Light Therapy compared to Dim Light Therapy in subjects with end stage kidney disease who are receiving hemodialysis to treat fatigue.
* To compare the effects of bright light therapy to dim light therapy on fatigue severity.
* To explore the effects of bright light therapy to dim light therapy on salivary cortisol.
* To compare the effects of bright light therapy to dim light therapy on insomnia, depression and quality of life.
* To test the effects on bright light therapy to dim light therapy on physical activity levels.
* To compare the effects of bright light therapy to dim light therapy on fatigue severity.
* To explore the effects of bright light therapy to dim light therapy on salivary cortisol.
* To compare the effects of bright light therapy to dim light therapy on insomnia, depression and quality of life.
* To test the effects on bright light therapy to dim light therapy on physical activity levels.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: