Light Therapy on Sleep Quality in Dialysis Patients

NCT04089397 | Completed

• 2 other identifiers: 17-11-LUMIDIAL2018-A02276-49
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure; Sleep Disorder; Hemodialysis; Light Therapy

Keywords

light therapy in sleep disorders of dialysis patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pathological sleep disorders defined by PSQI score > 5

  5 weeks

• Analysis of each component of the PSQI score

  5 weeks

• Anxious-depressive state of the patients

  5 weeks

• Impact of light therapy on nutritional intake of patients

  10 weeks

• Systolic Blood Pressure values

  10 weeks

Study Arms (2)

Light therapy group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Usual care, without light therapy

Interventions

Light Therapy DEVICE

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

Also known as: Lumie Brazil® (light therapy device for the treatment of seasonal affective disorders)

Light therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (1)

CH Annecy Genevois

Pringy, 74374, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Sleep Wake Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Benoit Franko, MD

  CH Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized open-label trial

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: October 1, 2019
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: December 2, 2020

Record last verified: 2019-11

Locations

FR (1)