Clinical trial NCT04089397: Light Therapy on Sleep Quality in Dialysis Patients
Official title: Randomized Open-label Trial Evaluating Light Therapy on Sleep Quality in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Sleep Disorder
Hemodialysis
Light Therapy
Keywords: light therapy in sleep disorders of dialysis patients
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open-label trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of light therapy on the quality of sleep of dialysis patients
timeFrame: 5 weeks
Secondary outcomes:
measure: Pathological sleep disorders defined by PSQI score > 5
timeFrame: 5 weeks
measure: Analysis of each component of the PSQI score
timeFrame: 5 weeks
measure: Anxious-depressive state of the patients
timeFrame: 5 weeks
measure: Impact of light therapy on nutritional intake of patients
timeFrame: 10 weeks
measure: Systolic Blood Pressure values
timeFrame: 10 weeks
measure: Diastolic Blood Pressure values
timeFrame: 10 weeks
measure: Side effects of light therapy
timeFrame: 5 weeks
measure: Impact of home care on the effectiveness of the primary endpoint
timeFrame: 5 weeks
measure: Evaluation of the residual duration of the effect of light therapy on sleep disorder
timeFrame: 5 weeks
measure: Evaluation of the residual duration of the effect of light therapy on anxious-depressive state of the patients
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Pringy
country: France
facility: CH Annecy Genevois
Study officials:
affiliation: CH Annecy Genevois
name: Benoit Franko, MD
role: PRINCIPAL_INVESTIGATOR
References: