Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2019-10-01
2020-05-11
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Light therapy group
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)
Light Therapy
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
Control group
Usual care, without light therapy
No interventions assigned to this group
Interventions
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Light Therapy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Annecy Genevois
OTHER
Responsible Party
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Principal Investigators
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Benoit Franko, MD
Role: PRINCIPAL_INVESTIGATOR
CH Annecy Genevois
Locations
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CH Annecy Genevois
Pringy, , France
Countries
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Other Identifiers
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2018-A02276-49
Identifier Type: OTHER
Identifier Source: secondary_id
17-11-LUMIDIAL
Identifier Type: -
Identifier Source: org_study_id