Assessment of Light Therapy in Insomnia Disorder

NCT05715411 | Recruiting

• 1 other identifier: 7680
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Change Sleep latency

  Actimetry is used to compare the sleep latency

  At day 0 and Day 44

Secondary Outcomes (3)

• Change Daytime sleepiness

  At day 0 and Day 90

• Change Daytime sleepiness

  At day 0 and Day 90

• Change Circadian rythms

  At day 0 and Day 90

Study Arms (2)

Control

PLACEBO COMPARATOR

Other: Placebo with light therapy glasses

Light therapy

EXPERIMENTAL

Other: light therapy with light therapy glasses

Interventions

Placebo with light therapy glasses OTHER

Placebo

Control

light therapy with light therapy glasses OTHER

light therapy

Light therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Patrice BOURGIN, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrice BOURGIN, MD

CONTACT

03 88 11 64 30; pbourgin@unistra.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: February 8, 2023
• Study Start: November 28, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)