Light therapy to help adults with insomnia fall asleep faster
Assessment of Light Therapy in Insomnia Disorder
This trial will test whether daily light delivered through special glasses helps adults aged 30–60 with insomnia fall asleep faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05715411 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 30–60 with chronic insomnia (ICSD-3) who take longer than 30 minutes to fall asleep at least three times per week, can consent, and are not shift workers or recent long-distance travelers.
Not a fit: People outside the 30–60 age range, those with other untreated sleep disorders, pregnant or breastfeeding women, shift workers, recent long-haul travelers, or patients taking medications that disturb sleep or melatonin measurements are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, this non-drug approach could shorten time to fall asleep and offer an alternative to hypnotic medications.
How similar studies have performed: Previous work on light therapy for circadian and sleep problems shows some positive effects, but its use specifically for insomnia is promising and less extensively tested than behavioral therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Strasbourg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.