Light Therapy in End Stage Kidney Disease

NCT ID: NCT06310161

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Bright Light

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

Group Type EXPERIMENTAL

Bright light

Intervention Type 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.

Dim Light

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

Group Type PLACEBO_COMPARATOR

Dim Light

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Re-Timer Re-Timer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lea Ann Matura, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Central Contacts

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Lea Ann Matura, PhD

Role: CONTACT

215 746 8819

Other Identifiers

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855161

Identifier Type: -

Identifier Source: org_study_id

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