Light Therapy for Chronic Insomnia in General Practice

NCT ID: NCT04612192

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2025-02-12

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

Conditions

Insomnia Chronic; Sleep Disorder; Circadian Rhythm Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active light

Active light

Group Type: EXPERIMENTAL

Active luminette

Intervention Type: DEVICE

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 light

Placebo light

Group Type: PLACEBO_COMPARATOR

Placebo luminette

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Nantes

Nantes, , France

CHU Reims

Reims, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

7348

Identifier Type: -

Identifier Source: org_study_id