- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06310161
Light Therapy in End Stage Kidney Disease
March 25, 2026 updated by: University of Pennsylvania
Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease
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.
Study Overview
Status
Recruiting
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lea Ann Matura, PhD
- Phone Number: 215 746 8819
- Email: matura@nursing.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Lea Ann Matura
- Phone Number: 713-410-1325
- Email: lamatura@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signed informed consent prior to initiation of any study mandated procedure
- Male and female participants ≥ 18 years of age
- Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month
- Fatigue Severity Scale (FSS) > 9 at enrollment
- Home refrigerator for salivary cortisol storage
Exclusion Criteria
- Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)
- Participants with photosensitivity (e.g. epilepsy)
- Hospitalized or acutely ill
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bright Light
Light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.
|
Bright light treatment will consist of using the Re-timer device 3 times per week during dialysis sessions for 4 weeks.
The Re-timer is worn like a pair of glasses and contains light emitting diodes mounted on the lower portion of the frame.
The Re-timer emits blue-green 500 nm light with an intensity of ~500 lux lm/m2.
Participants will be instructed to use the device for 60 minutes at the beginning of each dialysis session.
Other Names:
|
|
Placebo Comparator: Dim Light
Dim light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.
|
Dim light treatment will use non-light emitting glasses that look identical to Re-Timer for 4 weeks at each dialysis session following baseline assessments.
Participants will use the device for 60 minutes at the beginning of their dialysis session.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue Severity Scale
Time Frame: 4 weeks
|
Measures how bad or severe a person's fatigue is.
Score range from 9-63; higher scores indicate increased fatigue.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lea Ann Matura, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
January 2, 2024
First Submitted That Met QC Criteria
March 12, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- 855161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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