Actively Recruiting
Assessment of Light Therapy in Insomnia Disorder
Led by University Hospital, Strasbourg, France · Updated on 2025-08-08
66
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Assessment of Light Therapy in Insomnia Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 30 to 60 years
- Diagnosed with insomnia disorder (ICSD-3) with sleep latency over 30 minutes at least 3 times a week
- Able to understand the study and provide informed consent
- Affiliated with a social health insurance scheme
- Women of childbearing age must use effective contraception during the study
You will not qualify if you...
- Shift work in the year before enrollment
- Travel across more than 2 time zones in the month before enrollment
- Participation in another study exclusion period
- Unable to receive informed information due to emergency or comprehension issues
- Under judicial protection, guardianship, or curatorship
- Pregnant or breastfeeding women of childbearing age
- Use of drugs affecting sleep or melatonin measurement (corticosteroids, evening beta-blockers, exogenous melatonin)
- Phase delay syndrome as defined by ICSD-3
- Restless legs syndrome with IRLS score over 20
- Other psychiatric or addictive disorders (screened by MINI interview)
- Unstable medical conditions including chronic allergies, neurological, cardiovascular, respiratory, gastrointestinal, hematopoietic, visual, immune, kidney, urinary, endocrine, metabolic, infectious diseases, or epilepsy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
P
Patrice BOURGIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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