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NCT07729358

Overview

NCT ID: NCT07729358
Lead Sponsor: Centre Hospitalier Annecy GenevoisOTHER
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
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 15, 2026Estimated
Primary Completion Date: Sep 15, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 340Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts and Locations

Central Contacts: Alexandra RippozContact
arippoz@ch-annecygenevois.fr0033 4 85 52 21 20

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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