End-stage Chronic Kidney Disease Treated With HemodialysisLUMIDIAL-2NCT07729358
Evaluation of the Effect of Light Therapy on the Evolution of Self-reported Depressive Disorders in Chronic Hemodialysis Patients
A study testing Light therapy using active glasses and Light therapy using inactive glasses in people with End-stage Chronic Kidney Disease Treated With Hemodialysis and Depressive Disorders, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
Hemodialysis is an intensive treatment, with a lifestyle dictated by the organization of the dialysis center. This treatment is associated with a decrease in quality of life, an increase in sleep disorders, and depressive disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Chronic Kidney Disease Treated With Hemodialysis, Depressive Disorders
- What is being tested?
- Light therapy using active glasses and Light therapy using inactive glasses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2026to 15 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient informed about the nature, process, and objectives of the study and having signed a free and informed consent to participate,
- Patient treated with conventional hemodialysis for at least 3 months and currently undergoing dialysis 3 times a week,
- Patient covered by the french national social welfare
- Non-Inclusion Criteria:
- Patient who has initiated or modified antidepressive treatment within the 4 weeks prior to the inclusion visit,
- Patient with initiation of antidepressive treatment within the 10 weeks following the inclusion visit (screening and intervention periods),
Show all 21Show fewer
- Patient who has initiated or modified anxiolytic, hypnotic, or melatonin treatment within the 4 weeks prior to the inclusion visit,
- Patient presenting with binocular blindness or age-related macular degeneration (AMD),
- Patient receiving medical and/or surgical treatment for a retinal condition,
- Patient who has undergone ocular surgery within the 12 weeks prior to the inclusion visit,
- Patient scheduled for ocular surgery within the 10 weeks following the inclusion visit (screening and intervention periods),
- Patient suffering from neurocognitive disorders, schizophrenia or other primary psychotic disorders, or bipolar disorder or related conditions,
- Pregnant or breastfeeding patient,
- Patient unable to understand the French language both orally and in writing, making self-assessment impossible,
- Patient currently participating in another interventional research protocol, except for the IDE-3D protocol (RIPH2) conducted by the CH Annecy Genevois,
- Patient who has already been randomized in the present study,
- Patient under guardianship, curatorship, or placed under judicial protection.
- Randomisation criteria
- The patient will be considered eligible for randomization if they have a HADS-D screening score dated within a maximum of 15 days and meet one of the following two criteria:
- HADS-D screening score ≥ 8 and < 15,
- HADS-D screening score ≥ 15, provided that a medical follow-up assessment has been conducted following this diagnosis during the screening period, and that it does not lead to the recommendation for the initiation or modification of antidepressant treatment and/or psychotherapy within the 10 weeks following the inclusion visit (screening and intervention periods).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
DRCI CH Annecy Genevois contact
About this study
Official title: Randomized Trial Evaluating the Effect of Light Therapy Using Glasses Versus a Sham Device on the Evolution of Self-reported Depressive Disorders in Chronic Hemodialysis Patients
Hemodialysis is an intensive treatment, with a lifestyle dictated by the organization of the dialysis center. This treatment is associated with a decrease in quality of life, an increase in sleep disorders, and depressive disorders.
Light therapy could be a non-pharmacological option for treating depressive states in chronic hemodialysis patients. Indeed, the production of melatonin is stimulated by exposure to light of a defined intensity for 30 minutes in the morning. This hormone influences our sleep-wake cycle. In the general population, light therapy has demonstrated its benefits for depression. This practice could therefore improve sleep quality and mood in chronic hemodialysis patients who experience depressive symptoms.
The objective of this research is to evaluate the effect of light therapy on the reduction of depressive disorders experienced by chronic hemodialysis patients. Light therapy will be administered using glasses called "Luminette®," three times a week for five weeks, on the days of dialysis sessions in the morning at the center or at home for patients undergoing afternoon dialysis
Read the detailed description
In France, the prevalence of end-stage chronic kidney disease has been increasing for several years. Chronic hemodialysis constitutes an essential renal replacement therapy but imposes a constrained lifestyle due to recurrent sessions at the dialysis center. It is frequently accompanied by a deterioration in quality of life reported by patients and a high prevalence of depressive syndromes, estimated to be between 22% and 68%.
Despite this high frequency, the systematic screening of depressive symptoms is not uniformly integrated into the routine practice of dialysis centers, and there are no specific recommendations regarding the psychiatric management of dialysis patients. However, the Haute Autorité de Santé 2023 recommendations emphasize the importance of regular evaluation of quality of life and psychological burden in these patients using standardized tools.
Dialysis patients often exhibit disorganization of circadian rhythms, including alterations in melatonin production, accompanied by disturbances in the cortisol cycle (reduced pulsatility and daily overexposure). This disorganization of the cortisol cycle is also observed in depressive states. These circadian disturbances are often targeted by antidepressant treatments or by non-pharmacological approaches such as light therapy.
Light therapy is an intervention based on exposure to high-intensity white light (generally greater than 5000 Lux), preferably administered in the morning for approximately 30 minutes. It aims to resynchronize circadian rhythms, particularly through modulation of melatonin secretion. It has demonstrated efficacy on depressive symptoms in the general population, but few studies have evaluated its use in patients with renal failure.
A randomized trial showed a reduction in the Depression Anxiety and Stress Scale 21 (DASS-21) score in the light therapy group. An open-label study reported a significant decrease in depressive symptoms assessed by the Beck Depression Inventory-II (BDI-II). However, these studies have methodological limitations and did not evaluate a treatment regimen specifically adapted to the rhythm of hemodialysis sessions (three mornings or afternoons per week). In 2024, our pilot study LUMIDIAL-1 reported a trend toward decreased depressive states in hemodialysis patients exposed to light therapy, also confirming feasibility under real dialysis conditions. These preliminary results justify the establishment of a multicenter, randomized, controlled trial with a sham comparator and enhanced blinding to rigorously evaluate the efficacy of light therapy in chronic hemodialysis patients with depressive symptoms.
The coordinating investigator and the methodologist hypothesize that, in chronic hemodialysis patients presenting with self-reported depressive symptoms defined by a score ≥ 8 on the depression component of the Hospital Anxiety and Depression Scale (HADS-D), light therapy could reduce the intensity of depressive symptoms by contributing to the restoration of the melatonin and cortisol cycles. In the long term, this non-pharmacological intervention could improve quality of life and decrease reliance on psychotropic treatments.
- Being tested
- Light therapy using active glasses, Light therapy using inactive glasses
- Keywords
- Mental health, Light Therapy, Therapeutic and Preventive Strategies, Patient Quality of Life
- Medical subject headings
- Depressive Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapy using active glassesOther
Also called Active Luminette3®
Light therapy using active glasses with intensity 1000 Lux
Light therapy using inactive glassesOther
Also called Sham Luminette3®
Light therapy using active glasses with intensity 50 Lux
| Study group | Role | What they receive |
|---|---|---|
| Active Light Therapy | Experimental | Five weeks of light therapy using active glasses, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis (at home, for patients dialyzing the afternoon, or during dialysis for patients dialyzing in the morning) Receives: Other: Light therapy using active glasses |
| Sham Light Therapy | Sham comparator | Five weeks of light therapy using inactive glasses, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis (at home, for patients dialyzing the afternoon, or during dialysis for patients dialyzing in the morning) Receives: Other: Light therapy using inactive glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression score on the Hospital Anxiety and Depression Scale (HADS)
Depression score on the Hospital Anxiety and Depression Scale (HADS-D), is measured at the end-of-intervention visit (Visite 2) and compared between the group receiving active light therapy glasses and the group receiving sham glasses, taking into account its value at randomization (Visite 1).
The HADS-D score will be calculated by summing the 7 items of the depression subscale (corresponding to the even-numbered questions), each rated from 0 to 3, resulting in a total score ranging from 0 to 21:
- score between 0 and 7: absence of depressive symptoms.
- score between 8 and 10: potential presence of depressive symptoms.
- score between 11 and 14: presence of depressive symptoms
- score of 15 and above: suspicion of severe depressive disorder
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Chronic Kidney Disease Treated With HemodialysisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be centralized, with blinded allocation, via the trial's electronic platform. Patients will be allocated in a 1:1 ratio between the intervention group (active light therapy glasses) and the control group (sham glasses), using randomly drawn blocks of varying sizes. The randomization will be stratified according to: * The investigational center, * The intensity of self-reported depressive state at the time of randomization, determined from the pre-intervention score on the Hospital Anxiety and Depression Scale (HADS-D ≥ 11: yes/no), in order to account for a certain initial depression that may influence the effect of light therapy. Participation in the optional sub-study on the cortisol cycle (yes/no). In centers offering the sub-study, four lists will be established (HADS-D ≥ 11: yes/no, participation in the sub-study: yes/no). In centers not offering it, two independent randomization lists will be generated (HADS-D ≥ 11: yes/no).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de la Santé, France, Association France REIN, LUCIMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729358
- Sponsor's protocol ID
- 21-08
- Acronym
- LUMIDIAL-2
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2026
- Last updated
- 20 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating the Effect of Light Therapy Using Glasses Versus a Sham Device on the Evolution of Self-reported Depressive Disorders in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07729358
- Acronym / sponsor ID
- LUMIDIAL-2 / 21-08
- Keywords
- Mental health, Light Therapy, Therapeutic and Preventive Strategies, Patient Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Collaborators
- Direction Générale de la Santé, France, Association France REIN, LUCIMED
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 27 Jul 2026 (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.
Hemodialysis is an intensive treatment, with a lifestyle dictated by the organization of the dialysis center. This treatment is associated with a decrease in quality of life, an increase in sleep disorders, and depressive disorders.
Light therapy could be a non-pharmacological option for treating depressive states in chronic hemodialysis patients. Indeed, the production of melatonin is stimulated by exposure to light of a defined intensity for 30 minutes in the morning. This hormone influences our sleep-wake cycle. In the general population, light therapy has demonstrated its benefits for depression. This practice could therefore improve sleep quality and mood in chronic hemodialysis patients who experience depressive symptoms.
The objective of this research is to evaluate the effect of light therapy on the reduction of depressive disorders experienced by chronic hemodialysis patients. Light therapy will be administered using glasses called "Luminette®," three times a week for five weeks, on the days of dialysis sessions in the morning at the center or at home for patients undergoing afternoon dialysis
Detailed description
In France, the prevalence of end-stage chronic kidney disease has been increasing for several years. Chronic hemodialysis constitutes an essential renal replacement therapy but imposes a constrained lifestyle due to recurrent sessions at the dialysis center. It is frequently accompanied by a deterioration in quality of life reported by patients and a high prevalence of depressive syndromes, estimated to be between 22% and 68%.
Despite this high frequency, the systematic screening of depressive symptoms is not uniformly integrated into the routine practice of dialysis centers, and there are no specific recommendations regarding the psychiatric management of dialysis patients. However, the Haute Autorité de Santé 2023 recommendations emphasize the importance of regular evaluation of quality of life and psychological burden in these patients using standardized tools.
Dialysis patients often exhibit disorganization of circadian rhythms, including alterations in melatonin production, accompanied by disturbances in the cortisol cycle (reduced pulsatility and daily overexposure). This disorganization of the cortisol cycle is also observed in depressive states. These circadian disturbances are often targeted by antidepressant treatments or by non-pharmacological approaches such as light therapy.
Light therapy is an intervention based on exposure to high-intensity white light (generally greater than 5000 Lux), preferably administered in the morning for approximately 30 minutes. It aims to resynchronize circadian rhythms, particularly through modulation of melatonin secretion. It has demonstrated efficacy on depressive symptoms in the general population, but few studies have evaluated its use in patients with renal failure.
A randomized trial showed a reduction in the Depression Anxiety and Stress Scale 21 (DASS-21) score in the light therapy group. An open-label study reported a significant decrease in depressive symptoms assessed by the Beck Depression Inventory-II (BDI-II). However, these studies have methodological limitations and did not evaluate a treatment regimen specifically adapted to the rhythm of hemodialysis sessions (three mornings or afternoons per week). In 2024, our pilot study LUMIDIAL-1 reported a trend toward decreased depressive states in hemodialysis patients exposed to light therapy, also confirming feasibility under real dialysis conditions. These preliminary results justify the establishment of a multicenter, randomized, controlled trial with a sham comparator and enhanced blinding to rigorously evaluate the efficacy of light therapy in chronic hemodialysis patients with depressive symptoms.
The coordinating investigator and the methodologist hypothesize that, in chronic hemodialysis patients presenting with self-reported depressive symptoms defined by a score ≥ 8 on the depression component of the Hospital Anxiety and Depression Scale (HADS-D), light therapy could reduce the intensity of depressive symptoms by contributing to the restoration of the melatonin and cortisol cycles. In the long term, this non-pharmacological intervention could improve quality of life and decrease reliance on psychotropic treatments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization will be centralized, with blinded allocation, via the trial's electronic platform. Patients will be allocated in a 1:1 ratio between the intervention group (active light therapy glasses) and the control group (sham glasses), using randomly drawn blocks of varying sizes. The randomization will be stratified according to: * The investigational center, * The intensity of self-reported depressive state at the time of randomization, determined from the pre-intervention score on the Hospital Anxiety and Depression Scale (HADS-D ≥ 11: yes/no), in order to account for a certain initial depression that may influence the effect of light therapy. Participation in the optional sub-study on the cortisol cycle (yes/no). In centers offering the sub-study, four lists will be established (HADS-D ≥ 11: yes/no, participation in the sub-study: yes/no). In centers not offering it, two independent randomization lists will be generated (HADS-D ≥ 11: yes/no).
| Arm | Type | Receives |
|---|---|---|
| Active Light Therapy | Experimental | Other: Light therapy using active glassesFive weeks of light therapy using active glasses, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis (at home, for patients dialyzing the afternoon, or during dialysis for patients dialyzing in the morning) |
| Sham Light Therapy | Sham comparator | Other: Light therapy using inactive glassesFive weeks of light therapy using inactive glasses, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis (at home, for patients dialyzing the afternoon, or during dialysis for patients dialyzing in the morning) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patient informed about the nature, process, and objectives of the study and having signed a free and informed consent to participate,
- Patient treated with conventional hemodialysis for at least 3 months and currently undergoing dialysis 3 times a week,
- Patient covered by the french national social welfare
- Patient who has initiated or modified antidepressive treatment within the 4 weeks prior to the inclusion visit,
- Patient with initiation of antidepressive treatment within the 10 weeks following the inclusion visit (screening and intervention periods),
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Light therapy using active glassesAlso: Active Luminette3®Light therapy using active glasses with intensity 1000 Lux | Other | Active Light Therapy |
| Light therapy using inactive glassesAlso: Sham Luminette3®Light therapy using active glasses with intensity 50 Lux | Other | Sham Light Therapy |
Primary outcome
Depression score on the Hospital Anxiety and Depression Scale (HADS)
Time frame: 5 weeks
Depression score on the Hospital Anxiety and Depression Scale (HADS-D), is measured at the end-of-intervention visit (Visite 2) and compared between the group receiving active light therapy glasses and the group receiving sham glasses, taking into account its value at randomization (Visite 1). The HADS-D score will be calculated by summing the 7 items of the depression subscale (corresponding to the even-numbered questions), each rated from 0 to 3, resulting in a total score ranging from 0 to 21: * score between 0 and 7: absence of depressive symptoms. * score between 8 and 10: potential presence of depressive symptoms. * score between 11 and 14: presence of depressive symptoms * score of 15 and above: suspicion of severe depressive disorder
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
DRCI CH Annecy Genevois contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy using active glasses and Light therapy using inactive glasses in people with End-stage Chronic Kidney Disease Treated With Hemodialysis and Depressive Disorders, run by Centre Hospitalier Annecy Genevois at 1 site in France.
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 21 inclusion and 0 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: opening soon, as of the sponsor's last update on 20 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Rippoz (0033 4 85 52 21 20, arippoz@ch-annecygenevois.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression score on the Hospital Anxiety and Depression Scale (HADS) (time frame: 5 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 20 Oct 2026.