InsomniaInsomLumNCT05715411
Assessment of Light Therapy in Insomnia Disorder
A study testing light therapy with light therapy glasses in people with Insomnia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Insomnia
- What is being tested?
- light therapy with light therapy glasses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- - 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Patrice BOURGIN, MD, 03 88 11 64 30, pbourgin@unistra.fr
About this study
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.
Read more
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
- Being tested
- Placebo with light therapy glasses, light therapy with light therapy glasses
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo with light therapy glassesOther
Placebo
light therapy with light therapy glassesOther
light therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Other: Placebo with light therapy glasses |
| Light therapy | Experimental | Not described Receives: Other: light therapy with light therapy glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Sleep latency
Actimetry is used to compare the sleep latency
Measured: At day 0 and Day 44
Secondary outcomes (3)
Change Daytime sleepiness
Epworth Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention
Measured: 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
Measured: 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
Measured: At day 0 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start28 Nov 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice BOURGIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715411
- Sponsor's protocol ID
- 7680
- Acronym
- InsomLum
- Status last verified
- Aug 2026
- First submitted
- 4 Jan 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Light Therapy in Insomnia Disorder
- ClinicalTrials.gov ID
- NCT05715411
- Acronym / sponsor ID
- InsomLum / 7680
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Placebo with light therapy glasses |
| Light therapy | Experimental | Other: light therapy with light therapy glasses |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (20 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo with light therapy glassesPlacebo | Other | Control |
| light therapy with light therapy glasseslight therapy | Other | Light therapy |
Primary outcome
Change Sleep latency
Time frame: At day 0 and Day 44
Actimetry is used to compare the sleep latency
3 secondary outcomes
Change Daytime sleepiness
Time frame: At day 0 and Day 90
Change Daytime sleepiness
Time frame: At day 0 and Day 90
Change Circadian rythms
Time frame: At day 0 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrice BOURGIN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light therapy with light therapy glasses in people with Insomnia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrice BOURGIN, MD (03 88 11 64 30 ext. 0033, pbourgin@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Sleep latency (time frame: At day 0 and Day 44). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.