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Light Therapy for Chronic Insomnia in General Practice (Insolux)

Primary Purpose

Insomnia Chronic, Sleep Disorder, Circadian Rhythm Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active luminette
Placebo luminette
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Berlin 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

Sites / Locations

  • University of NantesRecruiting
  • CHU ReimsRecruiting
  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active light

Placebo light

Arm Description

active blue-enriched bright light

dim red placebo light

Outcomes

Primary Outcome Measures

Difference of sleep efficiency between active and placebo light condition
ratio of total sleep time on total time in bed in measured with actimetry
Difference of sleep efficiency between active and placebo light condition
ratio of total sleep time on total time in bed measured with actimetry

Secondary Outcome Measures

Full Information

First Posted
October 18, 2019
Last Updated
April 14, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT04612192
Brief Title
Light Therapy for Chronic Insomnia in General Practice
Acronym
Insolux
Official Title
Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
February 12, 2025 (Anticipated)
Study Completion Date
February 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic, Sleep Disorder, Circadian Rhythm Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active light
Arm Type
Experimental
Arm Description
active blue-enriched bright light
Arm Title
Placebo light
Arm Type
Placebo Comparator
Arm Description
dim red placebo light
Intervention Type
Device
Intervention Name(s)
Active luminette
Intervention Description
receive an active blue-enriched light-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
Intervention Type
Device
Intervention Name(s)
Placebo luminette
Intervention Description
receive a dim red-light placebo light (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 Outcome Measure Information:
Title
Difference of sleep efficiency between active and placebo light condition
Description
ratio of total sleep time on total time in bed in measured with actimetry
Time Frame
Before light therapy
Title
Difference of sleep efficiency between active and placebo light condition
Description
ratio of total sleep time on total time in bed measured with actimetry
Time Frame
After 4 weeks of light therapy

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
randomisation by sex
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette CHAMBE, MD
Phone
(0)3 88 79 08 02
Ext
+33
Email
juliette.chambe@unistra.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien ROUGERIE, MD
Phone
(0)3 88 80 00 73
Ext
+33
Email
frougerie@unistra.fr
Facility Information:
Facility Name
University of Nantes
City
Nantes
ZIP/Postal Code
44210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric RAT, MD
Email
Cedric.Rat@univ-nantes.fr
Facility Name
CHU Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline HURTAUD, MD
Email
aline.hurtaud@wanadoo.fr
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette CHAMBE, MD
Email
Juliette.chambe@unistra.fr
First Name & Middle Initial & Last Name & Degree
Eve RENAUD

12. IPD Sharing Statement

Plan to Share IPD
No

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Light Therapy for Chronic Insomnia in General Practice

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