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New treatment option for Insomnia
Official title Assessment of Light Therapy in Insomnia Disorder
ClinicalTrials.gov ID: NCT05715411
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60
You may be able to join if
- Patient aged 30 to 60 years
- Insomnia disorders (ICSD-3) with sleep latency \>30min - 3 times a week
- Patient able to understand the objectives and risks associated with the research and to give informed dated and signed consent
- Patient affiliated to a social health insurance scheme
- For women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD).
You likely can't join if
- \- Shift work in the year preceding inclusion
- Trans meridian travel (\> 2 time zones) in the month preceding inclusion
- Patient in exclusion period determined by a previous or ongoing study
- Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient)
- Patient under judicial protection
- Patient under guardianship or curatorship
See the full eligibility criteria
- Patient aged 30 to 60 years
- Insomnia disorders (ICSD-3) with sleep latency \>30min - 3 times a week
- Patient able to understand the objectives and risks associated with the research and to give informed dated and signed consent
- Patient affiliated to a social health insurance scheme
- For women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD).
- \- Shift work in the year preceding inclusion
- Trans meridian travel (\> 2 time zones) in the month preceding inclusion
- Patient in exclusion period determined by a previous or ongoing study
- Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient)
- Patient under judicial protection
- Patient under guardianship or curatorship
- For a woman of childbearing age: ongoing pregnancy or breastfeeding
- Drug 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-3
- Restless legs syndrome with IRLS score\> 20
- Other 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 allergies
- Neurological disorders
- cardiovascular, respiratory, gastrointestinal, hematopoietic, visual diseases
- diseases of the immune system
- kidney and urinary tract diseases
- endocrine and metabolic diseases
- infectious diseases
- epilepsy
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.