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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Annecy Genevois

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Light therapy using active glasses

    Other intervention

    Light therapy using active glasses with intensity 1000 Lux

  • Light therapy using inactive glasses

    Other intervention

    Light therapy using active glasses with intensity 50 Lux

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: Active Light TherapyExperimental treatment 1 intervention
Group B: Sham Light TherapySham comparator 1 intervention

Trial outcomes

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

Time frame
5 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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Centre Hospitalier Annecy Genevois

Lead sponsor

Direction Générale de la Santé, France

Collaborator

Association France REIN

Collaborator

LUCIMED

Collaborator

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