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Assessment of Light Therapy in Insomnia Disorder (InsomLum)

Primary Purpose

Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Placebo with light therapy glasses
light therapy with light therapy glasses
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient aged 30 to 60 years Insomnia disorders (ICSD-3) with sleep latency >30min - 3 times a week Patient able to understand the objectives and risks associated with the research and to give informed dated and signed consent Patient affiliated to a social health insurance scheme For women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD). Exclusion Criteria: - Shift work in the year preceding inclusion Trans meridian travel (> 2 time zones) in the month preceding inclusion Patient in exclusion period determined by a previous or ongoing study Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient) Patient under judicial protection Patient under guardianship or curatorship For a woman of childbearing age: ongoing pregnancy or breastfeeding Drug treatment which can disturb sleep or the measurement of DLMO: corticosteroids by general route, beta-blockers in the evening, exogenous melatonin. Phase delay syndrome defined according to the criteria of the international classification of ICSD-3 Restless legs syndrome with IRLS score> 20 Other psychiatric disorders or addictive disorder (screening with the MINI structured interview) Other medical conditions not stabilized (detected by clinical interview), only the diseases appearing in the following list will constitute a criterion of non-inclusion: Chronic allergies Neurological disorders cardiovascular, respiratory, gastrointestinal, hematopoietic, visual diseases diseases of the immune system kidney and urinary tract diseases endocrine and metabolic diseases infectious diseases epilepsy

Sites / Locations

  • Hôpitaux Universitaires de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Light therapy

Arm Description

Outcomes

Primary Outcome Measures

Change Sleep latency
Actimetry is used to compare the sleep latency

Secondary Outcome Measures

Change Daytime sleepiness
Epworth Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention
Change Daytime sleepiness
Karolinska Sleepiness Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention
Change Circadian rythms
Circadian markers melatonin is measured in baseline, completion of the procedure and three month after intervention

Full Information

First Posted
January 4, 2023
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT05715411
Brief Title
Assessment of Light Therapy in Insomnia Disorder
Acronym
InsomLum
Official Title
Assessment of Light Therapy in Insomnia Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
August 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 represent a major public health issue and the leader in these disorders is insomnia with 10 to 15% of subjects in the general population reporting symptoms of insomnia with a daytime impact. In addition to being very common, insomnia leads to an increase in morbidity and mortality and weighs on healthcare systems worldwide. Despite this public health context, insomnia is underdiagnosed and rarely treated. Hypnotics have proven efficacy but with a risk of dependence and pharmacotolerance which appears within a few weeks. Cognitive behavioral therapy (CBT) has a good level of evidence and is now a benchmark treatment for the management of insomnia. Unfortunately, not all patients adhere to or respond to these procedures, which cannot be implemented for many of them either. There is therefore a need to identify other alternative therapeutic strategies, and we believe that exposure to light is a promising treatment. In this perspective, it seems interesting to assess the effect of the propensity to fall asleep with an exposure to light therapy in patients suffering from insomnia. In order to be in optimal ecological conditions, we want to use a portable light therapy device which allows easy, acceptable and ambulatory exposure. If the lighttherapy is confirmed in insomnia under ecological conditions, this would make it possible to propose a new non-drug treatment, easy to access and on a large scale

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Light therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Placebo with light therapy glasses
Intervention Description
Placebo
Intervention Type
Other
Intervention Name(s)
light therapy with light therapy glasses
Intervention Description
light therapy
Primary Outcome Measure Information:
Title
Change Sleep latency
Description
Actimetry is used to compare the sleep latency
Time Frame
At day 0 and Day 44
Secondary Outcome Measure Information:
Title
Change Daytime sleepiness
Description
Epworth Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention
Time Frame
At day 0 and Day 90
Title
Change Daytime sleepiness
Description
Karolinska Sleepiness Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention
Time Frame
At day 0 and Day 90
Title
Change Circadian rythms
Description
Circadian markers melatonin is measured in baseline, completion of the procedure and three month after intervention
Time Frame
At day 0 and Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 30 to 60 years Insomnia disorders (ICSD-3) with sleep latency >30min - 3 times a week Patient able to understand the objectives and risks associated with the research and to give informed dated and signed consent Patient affiliated to a social health insurance scheme For women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD). Exclusion Criteria: - Shift work in the year preceding inclusion Trans meridian travel (> 2 time zones) in the month preceding inclusion Patient in exclusion period determined by a previous or ongoing study Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient) Patient under judicial protection Patient under guardianship or curatorship For a woman of childbearing age: ongoing pregnancy or breastfeeding Drug treatment which can disturb sleep or the measurement of DLMO: corticosteroids by general route, beta-blockers in the evening, exogenous melatonin. Phase delay syndrome defined according to the criteria of the international classification of ICSD-3 Restless legs syndrome with IRLS score> 20 Other psychiatric disorders or addictive disorder (screening with the MINI structured interview) Other medical conditions not stabilized (detected by clinical interview), only the diseases appearing in the following list will constitute a criterion of non-inclusion: Chronic allergies Neurological disorders cardiovascular, respiratory, gastrointestinal, hematopoietic, visual diseases diseases of the immune system kidney and urinary tract diseases endocrine and metabolic diseases infectious diseases epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice BOURGIN, MD
Phone
03 88 11 64 30
Ext
0033
Email
pbourgin@unistra.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice BOURGIN, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Light Therapy in Insomnia Disorder

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