Light Therapy for Chronic Insomnia in General Practice

Not Applicable

Completed

• Conditions: Insomnia Chronic; Sleep Disorder; Circadian Rhythm Disorders

• 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

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