Light Therapy for Chronic Insomnia in General Practice

Not Applicable

Completed

• Conditions: Insomnia Chronic; Sleep Disorder; Circadian Rhythm Disorders
• Interventions: Device: Placebo luminette; Device: Active luminette

• Registration Number: NCT04612192
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

* 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

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 Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-02
• Study Start: 2021-04-13
• Primary Completion: 2025-02-12
• Study Completion: 2025-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo light	Placebo luminette	Placebo light
Active light	Active luminette	Active light

Primary Outcome Measures

Name	Time	Method
Difference of sleep efficiency between active and placebo light condition	After 4 weeks of light therapy	ratio of total sleep time on total time in bed measured with actimetry

Trial Locations

Locations (3)

University of Nantes; 🇫🇷 Nantes, France

CHU Reims; 🇫🇷 Reims, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France