Insomnia ChronicInsoluxNCT04612192
Light Therapy for Chronic Insomnia in General Practice
A study testing Active luminette in people with Insomnia Chronic and Sleep Disorder, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insomnia Chronic, Sleep Disorder, Circadian Rhythm Disorders
- What is being tested?
- Active luminette
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Apr 2021to 12 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
University of Nantes
Nantes, 44210
CHU Reims
Reims, 51092
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study
- 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
Read the 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
- Conditions
- Insomnia Chronic, Sleep Disorder, Circadian Rhythm Disorders
- Being tested
- Active luminette, Placebo luminette
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active luminetteDevice
receive an active light using 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
Placebo luminetteDevice
receive a placebo light using glasses (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
| Study group | Role | What they receive |
|---|---|---|
| Active light | Experimental | Active light Receives: Device: Active luminette |
| Placebo light | Placebo comparator | Placebo light Receives: Device: Placebo luminette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of sleep efficiency between active and placebo light condition
ratio of total sleep time on total time in bed in measured with actimetry
Measured: Before light therapy
Difference of sleep efficiency between active and placebo light condition
ratio of total sleep time on total time in bed measured with actimetry
Measured: After 4 weeks of light therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start13 Apr 2021
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612192
- Sponsor's protocol ID
- 7348
- Acronym
- Insolux
- Status last verified
- Mar 2025
- First submitted
- 18 Oct 2019
- Last updated
- 12 Mar 2025
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT04612192
- Acronym / sponsor ID
- Insolux / 7348
- Conditions
- Insomnia Chronic, Sleep Disorder, Circadian Rhythm Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 2 Nov 2020 (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, 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active light | Experimental | Device: Active luminetteActive light |
| Placebo light | Placebo comparator | Device: Placebo luminettePlacebo light |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Active luminettereceive an active light using 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 | Device | Active light |
| Placebo luminettereceive a placebo light using glasses (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 | Device | Placebo light |
Primary outcome
Difference of sleep efficiency between active and placebo light condition
Time frame: Before light therapy
ratio of total sleep time on total time in bed in measured with actimetry
Difference of sleep efficiency between active and placebo light condition
Time frame: After 4 weeks of light therapy
ratio of total sleep time on total time in bed measured with actimetry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active luminette in people with Insomnia Chronic and Sleep Disorder, run by University Hospital, Strasbourg, France at 3 sites 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of sleep efficiency between active and placebo light condition (time frame: Before light therapy). The study lists 2 primary outcomes in all. 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 12 Mar 2025.