Clinical trial NCT04612192: Light Therapy for Chronic Insomnia in General Practice
Official title: Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Sleep Disorder
Circadian Rhythm Disorders
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Difference of sleep efficiency between active and placebo light condition
timeFrame: Before light therapy
measure: Difference of sleep efficiency between active and placebo light condition
timeFrame: After 4 weeks of light therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: University of Nantes
city: Reims
country: France
facility: CHU Reims
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: