Light Therapy on Sleep Quality in Dialysis Patients (LUMIDIAL)

Randomized Open-label Trial Evaluating Light Therapy on Sleep Quality in Dialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Hemodialysis; Chronic Renal Failure; Light Therapy
• Intervention / Treatment: Device: Light Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pringy, France, 74374
    • CH Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: 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 Names: Lumie Brazil® (light therapy device for the treatment of seasonal affective disorders)
No Intervention: Control group; Usual care, without light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of light therapy on the quality of sleep of dialysis patients	The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. The primary endpoint is the measured difference in PSQI score between baseline and 5 weeks post-exposure to light therapy between the two arms of the study (no light therapy versus active light therapy).	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological sleep disorders defined by PSQI score > 5	Percentage of patients with a PSQI score > 5 measured in both arms at baseline and after 5 weeks	5 weeks
Analysis of each component of the PSQI score	There are 7 components in the PSQI score (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. Difference of the medians obtained on each component of the PSQI score in both arms at baseline and after 5 weeks	5 weeks
Anxious-depressive state of the patients	The French Depression Anxiety Stress Scales (DASS 21) is a 21-item self-rated questionnaire designed to measure the emotional states of depression, anxiety and stress over the past week. The scale to which each item belongs is indicated by the letter D (Depression), A (Anxiety) and S (Stress). For each scale, scores are summed with the higher scores corresponding to the most severe status. Total score difference obtained from the questionnaire French Depression Anxiety Stress Scales (DASS 21) in both arms at baseline and after 5 weeks	5 weeks
Impact of light therapy on nutritional intake of patients	The normalized protein catabolic rate is a formula commonly used to assess dietary protein intake in dialysis patients, as a means towards determining nutritional adequacy. Absolute difference in Normalized Protein Catabolic Rate value in both arms at baseline, after 5 weeks and 10 weeks	10 weeks
Systolic Blood Pressure values	Absolute difference in systolic blood pressure in both arms at baseline, after 5 weeks and 10 weeks	10 weeks
Diastolic Blood Pressure values	Absolute difference in diastolic blood pressure in both arms at baseline, after 5 weeks and 10 weeks	10 weeks
Side effects of light therapy	Number and frequency of side effects	5 weeks
Impact of home care on the effectiveness of the primary endpoint	The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Difference in the average PSQI score between the two subgroups: home care versus during dialysis light therapy	5 weeks
Evaluation of the residual duration of the effect of light therapy on sleep disorder	The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Average difference in PSQI score at the end of the procedure and 5 weeks later.	5 weeks
Evaluation of the residual duration of the effect of light therapy on anxious-depressive state of the patients	The French Depression Anxiety Stress Scales (DASS 21) is a 21-item self-rated questionnaire designed to measure the emotional states of depression, anxiety and stress over the past week. The scale to which each item belongs is indicated by the letter D (Depression), A (Anxiety) and S (Stress). For each scale, scores are summed with the higher scores corresponding to the most severe status. Average difference in DASS 21 score, at the end of the procedure and 5 weeks later.	5 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois
• Investigators: Principal Investigator: Benoit Franko, MD, CH Annecy Genevois

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): May 11, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: light therapy in sleep disorders of dialysis patients
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Renal Insufficiency; Renal Insufficiency, Chronic; Sleep Wake Disorders; Parasomnias; Kidney Failure, Chronic
• Other Study ID Numbers: 17-11-LUMIDIAL; 2018-A02276-49 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No