BipolarBLUMENCT06748716
Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder
A study testing Blue-blocking glasses and Clear glasses in people with Bipolar and Manic, run by Rayan NASSERDINE at 1 site in Switzerland.
Trial summary
This study will be a randomized controlled trial (RCT) measuring the efficacy of wearing blue-blocking glasses (orange glasses) on manic symptoms in a population of patients suffering from Bipolar Disorder (BD), hospitalized for a manic episode on 10 days compared to non-filtering glasses (clear glasses, placebo) in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar, Manic, Bipolar Disorder (BD)
- What is being tested?
- Blue-blocking glasses and Clear glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2025to 1 Apr 2028
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized with manic symptoms in HUG
- Diagnostic of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
- aged 18-70 years
Who cannot join
- previous knowledge of blue-blocking glasses
- not consenting to participate
- severe eye disease or traumatic injury affecting both eyes.
- withdrawal symptoms from any drug or alcohol at the time of admission (the start of the intervention will be delayed until withdrawal symptoms have ceased)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Hopitaux Universitaires de Genève
Geneva, Suisse, 1225
Hélène RICHARD-LEPOURIEL, MD, MSc, PD, head of unit, +41 22 305 45 11, hlep@hug.ch
Rayan NASSERDINE, MD, clinical chef, +41 79 553 67 04, rnan@hug.ch
About this study
Official title: Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder: a Randomized Placebo-controlled Trial BLUME (Blue Light Filtering in Manic Episodes)
This study will be a randomized controlled trial (RCT) measuring the efficacy of wearing blue-blocking glasses (orange glasses) on manic symptoms in a population of patients suffering from Bipolar Disorder (BD), hospitalized for a manic episode on 10 days compared to non-filtering glasses (clear glasses, placebo) in addition to pharmacological treatment as usual.
The primary objective of this study is to evaluate the efficacity of orange glasses on improving manic symptoms in adult patients presenting BD in comparison with placebo. The primary outcome will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. Secondary objectives will be change in sleep quality, in motor activity (patterns of activity and rest), impact on psychotics symptoms, kinetics of the decrease of the manic symptoms from inclusion to the study and impact on maximal administered antipsychotic medication dosage ; they will be explored.
Read more
The investigators hypothesize that orange glasses is more effective than placebo in improving manic symptoms as an adjuvant treatment.
This project will take place in Alizé unit which is a newly conceived specialized ward dedicated to treating BD, at the HUG. The methodology has been developed in collaboration with the center of clinical research (CRC). The study will be conducted in accordance with established ethical and data management/protection practices.
Read the detailed description
The design of the study is a monocentric, single-blinded, two-arm parallel-group randomized placebo-controlled trial in a newly developed specialized mood disorder ward at the Geneva University Hospitals. The methodological aspects of this trial are elaborated in consultation with the Centre of Clinical Research (CRC) of our Hospital. The adjunctive treatment consists in wearing BBG for a few hours between 7pm and bedtime for ten days. Orange glasses (intervention) are from Melamedic®, type UV530 (Medical Device Class I - 93/42 EEC made in Denmark).
The adjunctive treatment will be compared to a placebo (clear-lensed glasses), both groups will also receive an active treatment as usual (the standard of care for treating manic episode following Swiss and international guidelines). No treatments are prohibited. All pharmacological treatments will be recorded. Due to the particularity of the device, the clinicians and the patient cannot be blind to the treatment condition (orange glasses vs clear glasses) which is an acknowledged limitation. The participants were masked to group assignment by receiving identical limited information about the purpose of the study : testing the effectiveness of different types of glasses in reducing manic symptoms by blocking different wavelengths of light. Patients will be randomized after eligibility has been established and written consent has been sought. If the patient capacity to consent is impaired, legal representative will be informed and capacity to consent will be re-assessed before each visit to obtain a written consent (delayed consent). Signs showing that the participant is unwilling to participate in the study will result in the participant exclusion (explicit refusal). The expected total duration of participation is 10 days. Data will be analyzed in an intention-to-treat design.
- Conditions
- Bipolar, Manic, Bipolar Disorder (BD), Dark Therapy, Actigraphy, Mania
- Being tested
- Blue-blocking glasses, Clear glasses
- Medical subject headings
- Mania, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue-blocking glassesDevice
The investigators hypothesize that blue-blocking glasses (intervention) is more effective than placebo.
Clear glassesDevice
Clear-lensed glasses are placebo
| Study group | Role | What they receive |
|---|---|---|
| Clear glasses | Placebo comparator | Not described Receives: Device: Clear glasses |
| Orange glasses | Experimental | Intervention group Receives: Device: Blue-blocking glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manics symptoms
The primary endpoint will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. The YMRS is a checklist of 11 items that are ranked on a scale of 0-4 or 0-8, the latter anchoring given to the four items which can be rated even with patients with poor cooperation. The score range therefore is between 0 and 60. This scale is classically used to assess the effectiveness of the treatment on manic symptoms. This is a clinical interview scale to assess the severity of manic states primarily used for research and it is designed to measure the severity of manic states, it can help guide clinicians on treatment planning and progress.
The investigators define a score of at least 20 points on the YMRS (> 20) to identify a manic state and the lower the score, the more the patient is in a state of euthymia (scale <2).
Measured: from baseline to day 10
Secondary outcomes (5)
Sleep quality
The investigators aim to assess the sleep quality for each participant by the Pittsburgh Sleep Quality Index (PSQI) and hypothesize that the patients receiving the intervention will have a better sleep quality.
The scale assesses a broad range of sleep domains and consists of 19 self-rated questions that measure seven components of sleep that are scored from 0 to 3: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction. The global score is the combination of the seven sub-scores and ranges therefore from 0 to 21, with higher scores for worse sleep quality; the cut-off point to define "poor sleepers" is >5.
Measured: from baseline to day 10
Psychotics symptoms
The investigators aim to assess the presence or absence of psychotics symptoms by the Positive and Negative Syndrome Scale (PANSS).
The scale has mostly been used to inventory, grade and follow the symptoms in schizophrenia. It quantifies positive symptoms, which refer to an excess or distortion of normal functions (e.g., hallucinations and delusions), and negative symptoms, which represent a diminution or loss of normal functions. The PANSS is composed of 3 subscales: Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112
Measured: from baseline to day 10
Kinectics of the decrease of manics symptoms
The investigators aim to assess the kinetics of the decrease of manics symptoms for each participtant and hypothesize that participants receiving the intervention will have a faster decrease in the Young Mania Rating Scale (YMRS).
Measured: from baseline to day 10
Impact on maximal administred antipsychotic medication dosage
The investigators aim to record the dosage of antipsychotic treatment for each patient and hypothesize that participants receiving the intervention will have lower dosage.
Measured: from baseline to day 10
Measure of the motor activity
The investigators aim to assess the intensity of the motor activity for each participant by actigraphy which is a noninvasive technique that measures physical activity levels of a subject by means of a wristwatch-like motion-sensing device that can be worn for prolonged periods of time. By use of a wrist-worn actigraph, motor activity will be continuously recorded for all groups.
They will be compared to data from a healthy control group.
Measured: from baseline to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BipolarStudies 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
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rayan NASSERDINE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rayan NASSERDINE, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748716
- Sponsor's protocol ID
- PRD 17-2024-II
- Acronym
- BLUME
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder: a Randomized Placebo-controlled Trial BLUME (Blue Light Filtering in Manic Episodes)
- ClinicalTrials.gov ID
- NCT06748716
- Acronym / sponsor ID
- BLUME / PRD 17-2024-II
- Conditions
- Bipolar, Manic, Bipolar Disorder (BD), Dark Therapy, Actigraphy, Mania
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Rayan NASSERDINEUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 27 Dec 2024 (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.
This study will be a randomized controlled trial (RCT) measuring the efficacy of wearing blue-blocking glasses (orange glasses) on manic symptoms in a population of patients suffering from Bipolar Disorder (BD), hospitalized for a manic episode on 10 days compared to non-filtering glasses (clear glasses, placebo) in addition to pharmacological treatment as usual.
The primary objective of this study is to evaluate the efficacity of orange glasses on improving manic symptoms in adult patients presenting BD in comparison with placebo. The primary outcome will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. Secondary objectives will be change in sleep quality, in motor activity (patterns of activity and rest), impact on psychotics symptoms, kinetics of the decrease of the manic symptoms from inclusion to the study and impact on maximal administered antipsychotic medication dosage ; they will be explored.
The investigators hypothesize that orange glasses is more effective than placebo in improving manic symptoms as an adjuvant treatment.
This project will take place in Alizé unit which is a newly conceived specialized ward dedicated to treating BD, at the HUG. The methodology has been developed in collaboration with the center of clinical research (CRC). The study will be conducted in accordance with established ethical and data management/protection practices.
Detailed description
The design of the study is a monocentric, single-blinded, two-arm parallel-group randomized placebo-controlled trial in a newly developed specialized mood disorder ward at the Geneva University Hospitals. The methodological aspects of this trial are elaborated in consultation with the Centre of Clinical Research (CRC) of our Hospital. The adjunctive treatment consists in wearing BBG for a few hours between 7pm and bedtime for ten days. Orange glasses (intervention) are from Melamedic®, type UV530 (Medical Device Class I - 93/42 EEC made in Denmark).
The adjunctive treatment will be compared to a placebo (clear-lensed glasses), both groups will also receive an active treatment as usual (the standard of care for treating manic episode following Swiss and international guidelines). No treatments are prohibited. All pharmacological treatments will be recorded. Due to the particularity of the device, the clinicians and the patient cannot be blind to the treatment condition (orange glasses vs clear glasses) which is an acknowledged limitation. The participants were masked to group assignment by receiving identical limited information about the purpose of the study : testing the effectiveness of different types of glasses in reducing manic symptoms by blocking different wavelengths of light. Patients will be randomized after eligibility has been established and written consent has been sought. If the patient capacity to consent is impaired, legal representative will be informed and capacity to consent will be re-assessed before each visit to obtain a written consent (delayed consent). Signs showing that the participant is unwilling to participate in the study will result in the participant exclusion (explicit refusal). The expected total duration of participation is 10 days. Data will be analyzed in an intention-to-treat design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear glasses | Placebo comparator | Device: Clear glasses |
| Orange glasses | Experimental | Device: Blue-blocking glassesIntervention group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients hospitalized with manic symptoms in HUG
- Diagnostic of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
- aged 18-70 years
Key exclusion criteria (4 listed)
- previous knowledge of blue-blocking glasses
- not consenting to participate
- severe eye disease or traumatic injury affecting both eyes.
- withdrawal symptoms from any drug or alcohol at the time of admission (the start of the intervention will be delayed until withdrawal symptoms have ceased)
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 |
|---|---|---|
| Blue-blocking glassesThe investigators hypothesize that blue-blocking glasses (intervention) is more effective than placebo. | Device | Orange glasses |
| Clear glassesClear-lensed glasses are placebo | Device | Clear glasses |
Primary outcome
Manics symptoms
Time frame: from baseline to day 10
The primary endpoint will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. The YMRS is a checklist of 11 items that are ranked on a scale of 0-4 or 0-8, the latter anchoring given to the four items which can be rated even with patients with poor cooperation. The score range therefore is between 0 and 60. This scale is classically used to assess the effectiveness of the treatment on manic symptoms. This is a clinical interview scale to assess the severity of manic states primarily used for research and it is designed to measure the severity of manic states, it can help guide clinicians on treatment planning and progress. The investigators define a score of at least 20 points on the YMRS (> 20) to identify a manic state and the lower the score, the more the patient is in a state of euthymia (scale <2).
5 secondary outcomes
Sleep quality
Time frame: from baseline to day 10
Psychotics symptoms
Time frame: from baseline to day 10
Kinectics of the decrease of manics symptoms
Time frame: from baseline to day 10
Impact on maximal administred antipsychotic medication dosage
Time frame: from baseline to day 10
Measure of the motor activity
Time frame: from baseline to day 10
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 27 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue-blocking glasses and Clear glasses in people with Bipolar and Manic, run by Rayan NASSERDINE at 1 site in Switzerland.
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 4 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: opening soon, as of the sponsor's last update on 27 Dec 2024. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manics symptoms (time frame: from baseline to day 10). 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 27 Dec 2024.