Light therapy to help adults with insomnia fall asleep faster

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 30 to 60 with insomnia (ICSD-3) and sleep latency over 30 minutes at least three times per week are randomized to receive either active light therapy via light-therapy glasses or a placebo version of the glasses. The intervention is delivered and monitored at Hôpitaux Universitaires de Strasbourg, with eligibility screening to exclude recent shift work, recent trans-meridian travel, pregnancy, certain medications, and other protections. Outcomes focus on sleep timing and latency and may include circadian markers such as dim light melatonin onset where measured. Participants must be able to give informed consent and comply with device use and clinic visits.

Why it matters

Who can join: the full rules

Inclusion 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).

Exclusion Criteria:

* \- 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

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

Study contacts

• Principal investigator: Patrice BOURGIN, MD — Hôpitaux Universitaires de Strasbourg
• Study coordinator: Patrice BOURGIN, MD
• Email: pbourgin@unistra.fr
• Phone: 03 88 11 64 30

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.