End Stage Renal Disease
Conditions
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.
Interventions
DEVICEBright 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.
DEVICEDim 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTLea Ann Matura, PhD
PRINCIPAL_INVESTIGATORLea Ann Matura, PhD
University of Pennsylvania
Outcome results
None listed