Light Therapy in End Stage Kidney Disease

End Stage Renal Disease Clinical Trial

Official title:

Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310161
• Other study ID #: 855161
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Lea Ann Matura, PhD
• Phone: 215 746 8819
• Email: matura[@]nursing.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Bright light
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.
• Dim Light
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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