NCT04612192

Light Therapy for Chronic Insomnia in General Practice

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Insomnia Chronic
• Sleep Disorder
• Circadian Rhythm Disorders

Interventions

Type	Name	Description
DEVICE	Active 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
DEVICE	Placebo 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

Timeline

• Start date: 2021-04-13
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2020-11-02
• Last updated: 2025-03-12

Locations

3 sites across 1 country: France