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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Depression score on the Hospital Anxiety and Depression Scale
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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),
- •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).
排除标准
- 未提供
研究组 & 干预措施
Active Light Therapy
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)
干预措施: Light therapy using active glasses (Other)
Sham Light Therapy
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)
干预措施: Light therapy using inactive glasses (Other)
结局指标
主要结局
Depression score on the Hospital Anxiety and Depression Scale
时间窗: 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).
Depression score on the Hospital Anxiety and Depression Scale (HADS)
时间窗: 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
次要结局
未报告次要终点