Light Therapy in End Stage Kidney Disease

University of Pennsylvania

Status: Enrolling

Conditions: End Stage Renal Disease

Treatments: Device: Dim Light; Device: Bright light

Study type: Interventional

Funder types: Other

Identifiers

NCT06310161

855161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Bright Light

Experimental group

Description:

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

Treatment:

Device: Bright light

Dim Light

Placebo Comparator group

Description:

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

Treatment:

Device: Dim Light