Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT04612192
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04612192
Study Brief:
Protocol Section:
NCT04612192