Light Therapy on Sleep Quality in Dialysis Patients (LUMIDIAL)

Centre Hospitalier Annecy Genevois

Status: Completed

Conditions: Hemodialysis; Sleep Disorder; Chronic Renal Failure; Light Therapy

Treatments: Device: Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04089397

2018-A02276-49 (Other Identifier)

17-11-LUMIDIAL

Details and patient eligibility

About

Sleep disorders are common in dialysis patients. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.

Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin.

Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.

Full description

Sleep disorders are common in dialysis patients. Indeed, several studies have reported that the prevalence of these disorders is higher than that of the general population. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.

Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin. Light therapy has been studied in several pathologies. In the context of renal insufficiency, only one randomized study was conducted in renal transplant patients: out of 30 patients, the effect of light therapy regained an 11-minute increase in sleep latency, an earlier awakening of 24 minutes, and a gain in the DASS-21 depression score of 1.7 points while there was no improvement in his three parameters in the control group. Interest in light therapy has also been evaluated in seasonal and non-seasonal depression. In a meta-analysis of 458 patients, light therapy adjuvant use was as effective as the addition of a second molecule.

Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.

We therefore wish to set up a clinical study to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients. The secondary objectives will be to specify the improved sleep parameters, to evaluate the impact on the anxious-depressive score, the arterial hypertension, and the nutritional state, and the residual effect of light therapy.

The aim of this trial is to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient in conventional hemodialysis or hemodiafiltration for at least 3 months
• Patient requiring a dialysis session three times a week in the investigational site
• Patient benefiting from a social security scheme
• Patient informed and having given his free and informed consent to participate in the study

Exclusion criteria

• Patient with binocular blindness and / or age-related macular degeneration
• Eye fatigue
• Patient who has undergone a recent eye surgery (less than 3 months) or for whom such an operation is planned in the next 20 weeks
• Patient taking medications known to be responsible for photosensitivity
• Pregnant or lactating woman
• Patient under guardianship or curatorship
• Patient unable to give free and informed consent

Exclusion during the study - premature stop

• Wishes of the patient or the physician
• Appearance of unexplained visual disturbances
• Kidney transplant

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Light therapy group

Experimental group

Description:

Five weeks of light therapy, 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)

Treatment:

Device: Light Therapy

Control group

No Intervention group

Description:

Usual care, without light therapy