An interventional study of Light therapy using active glasses and Light therapy using inactive glasses in End-stage Chronic Kidney Disease Treated With Hemodialysis and Depressive Disorders, sponsored by Centre Hospitalier Annecy Genevois. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Centre Hospitalier Annecy Genevois · Not applicable, Interventional, and Other
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
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.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's planned enrollment of 340 is above the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Centre Hospitalier Annecy Genevois is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
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Inclusion Criteria:
Non-Inclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Other: Light therapy using active glasses
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)
Other: Light therapy using inactive glasses
Light therapy using active glasses with intensity 1000 Lux
Also known as: Active Luminette3®
Light therapy using active glasses with intensity 50 Lux
Also known as: Sham Luminette3®
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
Time frame: 5 weeks
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Annecy Genevois