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Not Yet Recruiting NCT05715411

Assessment of Light Therapy in Insomnia Disorder

Conditions: Insomnia

Sex: All
Ages: 30 Years – 60 Years
Phase: NA
Enrollment: 66
Sponsor: University Hospital, Strasbourg, France

Location: France

Summary

Sleep disorders represent a major public health issue and the leader in these disorders is insomnia with 10 to 15% of subjects in the general population reporting symptoms of insomnia with a daytime impact. In addition to being very common, insomnia leads to an increase in morbidity and mortality and weighs on healthcare systems worldwide. Despite this public health context, insomnia is underdiagnosed and rarely treated. Hypnotics have proven efficacy but with a risk of dependence and pharmacotolerance which appears within a few weeks. Cognitive behavioral therapy (CBT) has a good level of evidence and is now a benchmark treatment for the management of insomnia. Unfortunately, not all patients adhere to or respond to these procedures, which cannot be implemented for many of them either. There is therefore a need to identify other alternative therapeutic strategies, and we believe that exposure to light is a promising treatment.In this perspective, it seems interesting to assess the effect of the propensity to fall asleep with an exposure to light therapy in patients suffering from insomnia.In order to be in optimal ecological conditions, we want to use a portable light therapy device which allows easy, acceptable and ambulatory exposure.If the lighttherapy is confirmed in insomnia under ecological conditions, this would make it possible to propose a new non-drug treatment, easy to access and on a large scale

Eligibility Criteria

Inclusion Criteria:Patient aged 30 to 60 yearsInsomnia disorders (ICSD-3) with sleep latency >30min - 3 times a weekPatient able to understand the objectives and risks associated with the research and to give informed dated and signed consentPatient affiliated to a social health insurance schemeFor women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD).Exclusion Criteria:- Shift work in the year preceding inclusionTrans meridian travel (> 2 time zones) in the month preceding inclusionPatient in exclusion period determined by a previous or ongoing studyImpossibility of giving the patient informed information (emergency patient, difficulty understanding the patient)Patient under judicial protectionPatient under guardianship or curatorshipFor a woman of childbearing age: ongoing pregnancy or breastfeedingDrug treatment which can disturb sleep or the measurement of DLMO: corticosteroids by general route, beta-blockers in the evening, exogenous melatonin.Phase delay syndrome defined according to the criteria of the international classification of ICSD-3Restless legs syndrome with IRLS score> 20Other psychiatric disorders or addictive disorder (screening with the MINI structured interview)Other medical conditions not stabilized (detected by clinical interview), only the diseases appearing in the following list will constitute a criterion of non-inclusion:Chronic allergiesNeurological disorderscardiovascular, respiratory, gastrointestinal, hematopoietic, visual diseasesdiseases of the immune systemkidney and urinary tract diseasesendocrine and metabolic diseasesinfectious diseasesepilepsy

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Source: ClinicalTrials.gov (NCT05715411). StuddyBuddy aggregates publicly available trial information.