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CompletedNCT04612192InsoluxUpdated Mar 12, 2025

Light Therapy for Chronic Insomnia in General Practice

An interventional study of Active luminette and Placebo luminette in Insomnia Chronic, Sleep Disorder and Circadian Rhythm Disorders, sponsored by University Hospital, Strasbourg, France. Completed at 3 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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
Read the 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

02

Conditions studied

  • Insomnia Chronic
  • Sleep Disorder
  • Circadian Rhythm Disorders
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 240 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Active light

    Active light

    Device: Active luminette

  • Placebo comparator
    Placebo light

    Placebo light

    Device: Placebo luminette

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

06

What researchers measure

Primary outcomes

  1. Difference of sleep efficiency between active and placebo light condition

    ratio of total sleep time on total time in bed in measured with actimetry

    Time frame: Before light therapy

  2. Difference of sleep efficiency between active and placebo light condition

    ratio of total sleep time on total time in bed measured with actimetry

    Time frame: After 4 weeks of light therapy

07

Study locations

3 sites
  • University of Nantes
    Nantes, 44210, France
  • CHU Reims
    Reims, 51092, France
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04612192
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Nov 2, 2020
Start date
Apr 13, 2021
Primary completion
Feb 12, 2025
Completion
Feb 12, 2025
Last update
Mar 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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