NCT04612192

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
1 year until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 13, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

October 18, 2019

Last Update Submit

March 10, 2025

Conditions

Insomnia ChronicSleep DisorderCircadian Rhythm Disorders

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Active light

EXPERIMENTAL

Active light

Device: Active luminette

Placebo light

PLACEBO COMPARATOR

Placebo light

Device: Placebo luminette

Interventions

Active luminetteDEVICE

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

Active light
Placebo luminetteDEVICE

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

Placebo light

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsrandomisation by sex
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Compliance with the treatment: the patient is able to have light therapy during the required time and at the agreed schedule.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Nantes

Nantes, 44210, France

Location

CHU Reims

Reims, 51092, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake DisordersChronobiology Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

November 2, 2020

Study Start

April 13, 2021

Primary Completion

February 12, 2025

Study Completion

February 12, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)