End Stage Renal DiseaseNCT06310161
Light Therapy in End Stage Kidney Disease
A study testing Bright light and Dim Light in people with End Stage Renal Disease, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Bright light and Dim Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of any study mandated procedure
- Male and female participants ≥ 18 years of age
- Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month
- Fatigue Severity Scale (FSS) > 9 at enrollment
- Home refrigerator for salivary cortisol storage
Who cannot join
- Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)
- Participants with photosensitivity (e.g. epilepsy)
- Hospitalized or acutely ill
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease
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.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Bright light, Dim Light
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright lightDevice
Also called Re-Timer
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 LightDevice
Also called Re-Timer
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.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light | Experimental | Light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions. Receives: Device: Bright light |
| Dim Light | Placebo comparator | Dim light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions. Receives: Device: Dim Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Measures how bad or severe a person's fatigue is. Score range from 9-63; higher scores indicate increased fatigue.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Feb 2026
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Ann Matura, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310161
- Sponsor's protocol ID
- 855161
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT06310161
- Acronym / sponsor ID
- 855161
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light | Experimental | Device: Bright lightLight therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions. |
| Dim Light | Placebo comparator | Device: Dim LightDim light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent prior to initiation of any study mandated procedure
- Male and female participants ≥ 18 years of age
- Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month
- Fatigue Severity Scale (FSS) > 9 at enrollment
- Home refrigerator for salivary cortisol storage
Key exclusion criteria (3 listed)
- Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)
- Participants with photosensitivity (e.g. epilepsy)
- Hospitalized or acutely ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright lightAlso: Re-TimerBright 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. | Device | Bright Light |
| Dim LightAlso: Re-TimerDim 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. | Device | Dim Light |
Primary outcome
Fatigue Severity Scale
Time frame: 4 weeks
Measures how bad or severe a person's fatigue is. Score range from 9-63; higher scores indicate increased fatigue.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Ann Matura, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light and Dim Light in people with End Stage Renal Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.