Light Therapy for Chronic Insomnia in General Practice (Insolux)

University Hospital, Strasbourg, France

Status: Completed

Conditions: Sleep Disorder; Circadian Rhythm Disorders; Insomnia Chronic

Treatments: Device: Active luminette; Device: Placebo luminette

Study type: Interventional

Funder types: Other

Identifiers

NCT04612192

7348

Details and patient eligibility

About

• 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

Full 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

Enrollment: 240 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Active light

Experimental group

Description:

Active light

Treatment:

Device: Active luminette

Placebo light

Placebo Comparator group

Description:

Placebo light

Treatment:

Device: Placebo luminette