Circadian Rhythm Disorders, Insomnia Chronic, Sleep Disorder
Conditions
Brief summary
* Sleep disorders, especially insomnia * Attention deficits (or disorders), daytime somnolence and drug dependence * The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice
Detailed description
Insomnia affects 15 to 20% of the general French adult population and increases with age. General practitioners (GPs) are the first confronted to sleep disorders, especially insomnia. Cognitive-behavioral therapies (CBT) have proven effective, but their implementation in everyday practice is limited, and alternative treatments are still needed. Light not only has a great influence on the sleep-wake cycle and alertness, but also on mood and cognitive functions. The administration time of light condition will be calculated for each individual in a modality that has no impact on the circadian phase. Study will be conduct on an outpatient basis in general practice
Interventions
DEVICEActive luminette
receive an active light using glasses of 1500 lux (an average of 180 photons/s/cm2, with a maximum wavelenght at 468 nm), 30-minute long light therapy in the morning, in a time period defined by sleep log and chronotype questionnaire, on a 4-week period
DEVICEPlacebo luminette
receive a placebo light using glasses (an average of n photons/s/cm2, single- band spectrum with a narrow peak at 660 nm under 50 lux), with the same modality as the experimental group
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Complaining of chronic insomnia according to ICSD-3 (International Classification of Sleep Disorders) criteria and/or taking hypnotics at least 3 nights per week for more than 3 months. * Non-hypnotic medication: stable medication during one month preceding the inclusion and for the 8 weeks of the study. * Compliance with the treatment: the patient is able to have light therapy during the required time and at the agreed schedule.
Exclusion criteria
* Severe psychiatric disorder (severe major depression, schizophrenia, bipolar disorder), obvious acute psychiatric comorbidity. * Untreated intrinsic sleep pathology: sleep apnea syndrome based on clinical criteria: STOP-BANG questionnaire score, restless legs syndrome manifesting more than 2 times a week and/or requiring treatment. * Mild to severe dementia. * Neurodegenerative sleep troubles * Severe intercurrent pathology. * Ophthalmic troubles presenting a contraindication to light therapy: retinopathy, age-related macular degeneration, diabetic retinopathy, macular hole, epiretinal membrane); lens opacifications (cataract) justifying surgery (correction of poor visual acuity, visual discomfort); glaucomatous and non-glaucomatous optic neuropathy resulting in visual impairement. * Toxicomania, chronic alcoholism. * Secondary insomnia linked to somatic non-stabilized pathology. * Elements influencing circadian rhythm * Pregnancy, breastfeeding. * Participation in another interventional clinical trial which includes an exclusion period * No information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.) * Patient under guardianship * Non hypnotic treatment potentially inducing a level 3 sleepiness one week before
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of sleep efficiency between active and placebo light condition | Before light therapy | ratio of total sleep time on total time in bed in measured with actimetry |
Countries
France
Outcome results
None listed