Light Therapy for Chronic Insomnia in General Practice (Insolux)

Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study

• Sleep disorders, especially insomnia
• Attention deficits (or disorders), daytime somnolence and drug dependence
• The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Insomnia Chronic; Circadian Rhythm Disorders
• Intervention / Treatment: Device: Active luminette; Device: Placebo luminette

Detailed Description

Insomnia affects 15 to 20% of the general French adult population and increases with age. General practitioners (GPs) are the first confronted to sleep disorders, especially insomnia.

Cognitive-behavioral therapies (CBT) have proven effective, but their implementation in everyday practice is limited, and alternative treatments are still needed.

Light not only has a great influence on the sleep-wake cycle and alertness, but also on mood and cognitive functions.

The administration time of light condition will be calculated for each individual in a modality that has no impact on the circadian phase.

Study will be conduct on an outpatient basis in general practice

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44210
    • University of Nantes
  • Reims, France, 51092
    • Chu Reims
  • Strasbourg, France, 67091
    • Hopitaux universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Complaining of chronic insomnia according to ICSD-3 (International Classification of Sleep Disorders) criteria and/or taking hypnotics at least 3 nights per week for more than 3 months.
• Non-hypnotic medication: stable medication during one month preceding the inclusion and for the 8 weeks of the study.
• Compliance with the treatment: the patient is able to have light therapy during the required time and at the agreed schedule.

Exclusion Criteria:

• Severe psychiatric disorder (severe major depression, schizophrenia, bipolar disorder), obvious acute psychiatric comorbidity.
• Untreated intrinsic sleep pathology: sleep apnea syndrome based on clinical criteria: STOP-BANG questionnaire score, restless legs syndrome manifesting more than 2 times a week and/or requiring treatment.
• Mild to severe dementia.
• Neurodegenerative sleep troubles
• Severe intercurrent pathology.
• Ophthalmic troubles presenting a contraindication to light therapy: retinopathy, age-related macular degeneration, diabetic retinopathy, macular hole, epiretinal membrane); lens opacifications (cataract) justifying surgery (correction of poor visual acuity, visual discomfort); glaucomatous and non-glaucomatous optic neuropathy resulting in visual impairement.
• Toxicomania, chronic alcoholism.
• Secondary insomnia linked to somatic non-stabilized pathology.
• Elements influencing circadian rhythm
• Pregnancy, breastfeeding.
• Participation in another interventional clinical trial which includes an exclusion period
• No information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)
• Patient under guardianship
• Non hypnotic treatment potentially inducing a level 3 sleepiness one week before

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active light	Device: Active luminette; receive an active light using glasses of 1500 lux (an average of 180 photons/s/cm2, with a maximum wavelenght at 468 nm), 30-minute long light therapy in the morning, in a time period defined by sleep log and chronotype questionnaire, on a 4-week period
Placebo Comparator: Placebo light	Device: Placebo luminette; receive a placebo light using glasses (an average of n photons/s/cm2, single- band spectrum with a narrow peak at 660 nm under 50 lux), with the same modality as the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of sleep efficiency between active and placebo light condition	ratio of total sleep time on total time in bed in measured with actimetry	Before light therapy
Difference of sleep efficiency between active and placebo light condition	ratio of total sleep time on total time in bed measured with actimetry	After 4 weeks of light therapy

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Chronobiology Disorders
• Other Study ID Numbers: 7348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No