Light Therapy for Chronic Insomnia in General Practice

Sleep Disorder Clinical Trial

— Insolux  

Official title:

Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612192
• Other study ID #: 7348
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: February 12, 2025

Study information

• Verified date: April 2023
• Source: University Hospital, Strasbourg, France
• Contact: Juliette CHAMBE, MD
• Phone: (0)3 88 79 08 02
• Email: juliette.chambe[@]unistra.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: February 12, 2025
• Est. primary completion date: February 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Disease
• Insomnia Chronic
• Sleep Disorder
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Device:
• Active luminette
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 luminette
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

Locations

Country	Name	City	State
France	University of Nantes	Nantes
France	CHU Reims	Reims
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of sleep efficiency between active and placebo light condition	ratio of total sleep time on total time in bed in measured with actimetry	Before light therapy
Primary	Difference of sleep efficiency between active and placebo light condition	ratio of total sleep time on total time in bed measured with actimetry	After 4 weeks of light therapy