Evaluation of the Effect of Light Therapy on the Evolution of Self-reported Depressive Disorders in Chronic Hemodialysis Patients

NCT07729358 | Not Yet Recruiting

• 1 other identifier: 21-08
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Depressive Disorders; End-stage Chronic Kidney Disease Treated With Hemodialysis

Keywords

Mental health; Light Therapy; Therapeutic and Preventive Strategies; Patient Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

  5 weeks

Study Arms (2)

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)

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)

Other: Light therapy using inactive glasses

Interventions

Light therapy using active glasses OTHER

Light therapy using active glasses with intensity 1000 Lux

Also known as: Active Luminette3®

Active Light Therapy

Light therapy using inactive glasses OTHER

Light therapy using active glasses with intensity 50 Lux

Also known as: Sham Luminette3®

Sham Light Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 presenting with binocular blindness or age-related macular degeneration (AMD),
• Patient receiving medical and/or surgical treatment for a retinal condition,
• 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,

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• Direction Générale de la Santé, France: collaborator
• Association France REIN: collaborator
• LUCIMED: collaborator

Study Sites (1)

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

Location

MeSH Terms

Conditions

Depressive Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Central Study Contacts

Alexandra Rippoz

CONTACT

0033 4 85 52 21 20; arippoz@ch-annecygenevois.fr

DRCI CH Annecy Genevois

CONTACT

drci.promotion@ch-annecygenevois.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)