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OpenTrials
Completed

NCT Number: NCT04612192

Light Therapy for Chronic Insomnia in General Practice

* 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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nantes, Nantes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active luminette

Device

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

Placebo luminette

Device

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: Insolux

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2020
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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