Light Therapy in End Stage Kidney Disease

NCT06310161 | Recruiting

• 1 other identifier: 855161
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Scale

  Measures how bad or severe a person's fatigue is. Score range from 9-63; higher scores indicate increased fatigue.

  4 weeks

Study Arms (2)

Bright Light

EXPERIMENTAL

Light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.

Device: Bright light

Dim Light

PLACEBO COMPARATOR

Dim light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.

Device: Dim Light

Interventions

Bright light DEVICE

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.

Also known as: Re-Timer

Bright Light

Dim Light DEVICE

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.

Also known as: Re-Timer

Dim Light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)
• Participants with photosensitivity (e.g. epilepsy)
• Hospitalized or acutely ill

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lea Ann Matura, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Ann Matura, PhD

CONTACT

215 746 8819; matura@nursing.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: March 15, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)