- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04612192
Light Therapy for Chronic Insomnia in General Practice (Insolux)
Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study
- 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
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Juliette CHAMBE, MD
- Phone Number: +33 (0)3 88 79 08 02
- Email: juliette.chambe@unistra.fr
Study Contact Backup
- Name: Fabien ROUGERIE, MD
- Phone Number: +33 (0)3 88 80 00 73
- Email: frougerie@unistra.fr
Study Locations
-
-
-
Nantes, France, 44210
- Recruiting
- University of Nantes
-
Contact:
- Cédric RAT, MD
- Email: Cedric.Rat@univ-nantes.fr
-
Reims, France, 51092
- Recruiting
- Chu Reims
-
Contact:
- Aline HURTAUD, MD
- Email: aline.hurtaud@wanadoo.fr
-
Strasbourg, France, 67091
- Recruiting
- Hopitaux Universitaires de Strasbourg
-
Contact:
- Juliette CHAMBE, MD
- Email: Juliette.chambe@unistra.fr
-
Contact:
- Eve RENAUD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active light
active blue-enriched bright light
|
receive an active blue-enriched light-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
|
Placebo Comparator: Placebo light
dim red placebo light
|
receive a dim red-light placebo light (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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of sleep efficiency between active and placebo light condition
Time Frame: Before light therapy
|
ratio of total sleep time on total time in bed in measured with actimetry
|
Before light therapy
|
Difference of sleep efficiency between active and placebo light condition
Time Frame: After 4 weeks of light therapy
|
ratio of total sleep time on total time in bed measured with actimetry
|
After 4 weeks of light therapy
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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