Light Therapy in End Stage Kidney Disease

Not Applicable

Not yet recruiting

• Conditions: End Stage Renal Disease
• Interventions: Device: Dim Light; Device: Bright light

• Registration Number: NCT06310161
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Study Start: 2026-01-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Signed informed consent prior to initiation of any study mandated procedure
2. Male and female participants ≥ 18 years of age
3. Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month
4. Fatigue Severity Scale (FSS) > 9 at enrollment
5. Home refrigerator for salivary cortisol storage

Exclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dim Light	Dim Light	Dim light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.
Bright Light	Bright light	Light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	4 weeks	Measures how bad or severe a person's fatigue is. Score range from 9-63; higher scores indicate increased fatigue.