Light Therapy for Chronic Insomnia in General Practice | NCT04612192

Studies
Light Therapy for Chronic Insomnia in General Practice

NCT04612192

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Mar 12, 2025Actual

Enrollment

240Actual

Phase

Not Applicable

Conditions

Insomnia Chronic
Sleep Disorder
Circadian Rhythm Disorders

Interventions

Active luminette
Placebo luminette

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2021Actual

Primary Completion Date

Feb 12, 2025Actual

Completion Date

Feb 12, 2025Actual

First Submitted Date

Oct 18, 2019

First Submission Date that Met QC Criteria

Oct 30, 2020

First Posted Date

Nov 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 12, 2025Actual

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active light	Experimental	Active light	Device: Active luminette
Placebo light	Placebo Comparator	Placebo light	Device: Placebo luminette

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

randomisation by sex

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Nantes		Nantes		44210	France
CHU Reims

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D012893	Sleep Wake Disorders
D021081	Chronobiology Disorders

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D009422	Nervous System Diseases
D001523	Mental Disorders