Assessment of Light Therapy in Insomnia Disorder (InsomLum)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Other: Placebo with light therapy glasses; Other: light therapy with light therapy glasses

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrice BOURGIN, MD; Phone Number: 0033 03 88 11 64 30; Email: pbourgin@unistra.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Placebo with light therapy glasses; Placebo
Experimental: Light therapy	Other: light therapy with light therapy glasses; light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Sleep latency	Actimetry is used to compare the sleep latency	At day 0 and Day 44

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Daytime sleepiness	Epworth Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention	At day 0 and Day 90
Change Daytime sleepiness	Karolinska Sleepiness Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention	At day 0 and Day 90
Change Circadian rythms	Circadian markers melatonin is measured in baseline, completion of the procedure and three month after intervention	At day 0 and Day 90

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Patrice BOURGIN, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 7680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No