Light Therapy for Chronic Insomnia in General Practice (NCT04612192) | Clinical Trial Compass
CompletedNot Applicable
Light Therapy for Chronic Insomnia in General Practice
France240 participantsStarted 2021-04-13
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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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 w…
What they're measuring
1
Difference of sleep efficiency between active and placebo light condition
Timeframe: Before light therapy
2
Difference of sleep efficiency between active and placebo light condition