InsomniaBATCAT-pilotNCT07433491
Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry
A study testing Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone in people with Insomnia and Delayed Sleep Phase Disorder, run by Helse Fonna at 2 sites in Norway.
Trial summary
Sleep problems and regulation difficulties are frequent in the child and adolescent psychiatry population. Insomnia and delayed sleep-wake phase disorders (DSPWD) are highly prevalent, and risk factors for developing more severe illness courses and chronic disorders. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Insomnia, Delayed Sleep Phase Disorder, Hyperarousal
- What is being tested?
- Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Mar 2026to 1 Jun 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-18 years, receiving health-care from child and adolescent mental health services at UPA University Hospital of North Norway, Tromsø or BUP Haugesund Hospital, Haugesund
- Current Insomnia or DSPD comorbid to one or several pychiatric symptom presentations or diagnoses
- Able and willing to provide written informed consent
- Participants aged 12-15,9 years also need consent from both parents/carers
- Able to comply with protocol
- Able to discontinue melatonin or BB-glasses if currently used, with at least 3 days washout period
Who cannot join
- Not able to comply with protocol for a required minimum of one night
- Blindness or severely reduced translucency of both eyes
- Known malformation or damage of optical tract blindness
- Use of melatonin all formulas that cannot be paused
- High risk for suicide or self-harm
- Consent from both partents/carers unlikely (participants age 12-15,9 years)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
BUP Haugesund
Haugesund, Rogaland, 5520
Sigrund Drivenes, MSc, 004752732805, sigrund.drivenes@helse-fonna.no
Georg W Reinhardt, MD, 004752732805, georg.walter.reinhardt@helse-fonna.no
- Not yet recruiting
BUPA Tromsø, The University Hospital of North Norway
Tromsø, Troms, 9019
Christian Eckhoff, MD, PhD, +47761700700 ext. +47, christian.eckhoff@uit.no
Judeson Joseph, MD, +4776170700 ext. +47, judeson.joseph@unn.no
About this study
Official title: Blue-blocking Glasses for Treating Evening Activation and Sleep Disorders in Child and Adolescent Psychiatry - a Pilot Trans-diagnostic Randomized Controlled Trial.
Sleep problems and regulation difficulties are frequent in the child and adolescent psychiatry population. Insomnia and delayed sleep-wake phase disorders (DSPWD) are highly prevalent, and risk factors for developing more severe illness courses and chronic disorders. Pharmacological treatments of sleep disorders dominate even for the youngest patients but are unsupported by long-term data on outcome and side effects. The majority of non-pharmacological treatment options are composite and resource demanding. The investigators will examine the effects and feasibility of the isolated intervention of evening/night use of blue-blocking glasses/real darkness as adjunctive treatment for insomnia and delayed sleep phase disorder in inpatient and outpatient settings for children and adolecents.
Read the detailed description
The investigators will conduct a pilot study to examine the effect and feasibility of blue-blocking glasses as adjunctive treatment for insomnia and delayed sleep phase disorder in child and adolescent inpatients and outpatient settings. If the intervention and protocol are feasible and promising with regards to clinical and physiological effects, the study will provide a sound base for planning larger multicenter RCT's. Blue-blocking glasses are a minimal risk, low-cost intervention, and have potential to improve illness-course through improved sleep and healthier circadian function. The intervention may reduce the need for pharmacological treatment for sleep and circadian disorders and enhance coping strategies for the adolescents and their caregivers. Lastly, the pilot study will yield much needed data on light conditions (daylight and nightlight) in hospital environments for children and adolescents and may contribute to improved sleep conditions in hospital wards.
- Conditions
- Insomnia, Delayed Sleep Phase Disorder, Hyperarousal, Transdiagnostic Psychopathology, Child and Adolescent Psychiatry
- Being tested
- Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone, Control
- Keywords
- children, adolescents, child and adolescent psychiatry, insomnia, delayed sleep phase disorder, hyperarousal, sleep, hospital ward, outpatients, Blue-blocking glasses, virtual dark therapy, blue-blocking interventention, mobile-phone, screen, actigraphy, 6-sulfatoxymelatonin, Heart Rate Variability, light, activation, melatonin
- 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.
Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phoneDevice
Also called Virtual darkness, Orange glasses, Amber lenses, Blue-blocking light filters
Blue-blocking glasses and night mode on mobile phoneBlue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participant's mobile phone screen (%) + treatment as usual
ControlOther
Also called Dark mode, Night mode
Application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on particpants's mobile phone screen (%) + Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Blue-blocking glasses | Experimental | Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participant's mobile phone screen (%) + treatment as usual Receives: Device: Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone |
| Dark mode (mobile phone) | Active comparator | Application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participants' mobile phone screen (%) + treatment as usual Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form baseline in sleep onset latency (SOL) at 1 week
Sleep onset latency (minutes) subjectively assessed in sleep diary and objectively assessed from actigraphy derived sleep parameters. Sleep onset latency describes how long it takes to fall asleep from the moment the person tries to fall asleep to sleep starts.
Measured: From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.
Change from baseline in overnight melatonin production at 1 week
Quantity of melatonin metabolite 6-sulphatoxymelatonin (aMT6s) in the total overnight urine volume (µg).
Measured: From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.
Secondary outcomes (9)
Affektive Reactivity Index, relf reported (ARI-S)
Self-report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome.
Measured: From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
Self-report Generalized Anxiety Disorder -7 (GAD-7)
GAD-7 is 7- item self-report questionnaire used for rating general symptoms of anxiety, minimum value 7, maximum value 28, high score indicates worse outcome.
Measured: From baseline to after 7 days of intervention. For outpatients, ARI-S and ARI-P are also assessed after 14 days of intervention.
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a nine-item self-report questionnaire rating depressive symptoms, minimum value 9, maximum value 36, high score indicate worse outcome.
Measured: From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
KID-SCREEN-10
The KID-SCREEN 10 is self report instrument for assessing quality of life for children and adolescents, minimum value 10, maxium value 50, high score indicates better outcome.
Measured: From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.
Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ)
The r-MEQ is a self report questionnaire for assessing morning or evening preference of the sleep/wake cycle, minimum value 4, maximum value 25, high score indicates morning type ("lark"), low score indicates evening type ("owl").
Measured: From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.
Bergen Insomnia Scale (BIS)
BIS is a self report questionnaire for diagnostic support (insomnia) and as a contiunous outcome variable. We will use BIS in the inclusion procedure but also repeat it as a subjective outcome measure of sleep problems and daytime function. Minimum value 0, maksimum value 42, high score indicate worse outcome.
Measured: From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.
Motor activity
GENEActive wristworn actigraph with RGB light sensor, (Active Insights, Manchester, UK). Motor activity/motor activity derived sleep outcomes (other than primary outcome) include: Total sleep time (sleep diary, actigraphy)
- Wake after sleep onset
- Motor activity in sleep interval
- Sleep efficency
- Sleep onset
- Sleep offset
- Mid-sleep time
- Motor activity patterns (circadian, motor variabilty, complexity)
Measured: From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
BioPoint biosensor
The BioPoint sensor is a physiological multisensor worn as a watch measuring heart rate, heart rate variability, peripheral skin impedance, peripheral temperature
Measured: During first and 7th day of intervention (inpatients), during 7th and 14 days of intervention (outpatients) For all patients the outcomes will be compared to baseline assessments.
Affektive Reactivity Index, parent-reported (ARI-P)
Proxy (care-giver) report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome.
Measured: From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Model description
- Pilot RCT and feasibility study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, University of Oslo, University Hospital of North Norway, Helse Vest
- Responsible party
- Sponsor
- Investigators
- Tone Elise G Henriksen, MD PhD, Principal investigator, Helse Fonna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433491
- Sponsor's protocol ID
- 6130-6130
- Other IDs
- F-12812, 593439, 764677
- Acronym
- BATCAT-pilot
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from GENEActiv, Biopoint and LYS-devices may be shared for IPD meta-analyses.
Publications
Esaki Y, Kitajima T, Ito Y, Koike S, Nakao Y, Tsuchiya A, Hirose M, Iwata N. Wearing blue light-blocking glasses in the evening advances circadian rhythms in the patients with delayed sleep phase disorder: An open-label trial. Chronobiol Int. 2016;33(8):1037-44. doi: 10.1080/07420528.2016.1194289. Epub 2016 Jun 20.
PubMed 27322730Kallestad H, Langsrud K, Simpson MR, Vestergaard CL, Vethe D, Kjorstad K, Faaland P, Lydersen S, Morken G, Ulsaker-Janke I, Saksvik SB, Scott J. Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled trial. PLoS Med. 2024 Dec 6;21(12):e1004380. doi: 10.1371/journal.pmed.1004380. eCollection 2024 Dec.
PubMed 39642162Henriksen TEG, Gronli J, Assmus J, Fasmer OB, Schoeyen H, Leskauskaite I, Bjorke-Bertheussen J, Ytrehus K, Lund A. Blue-blocking glasses as additive treatment for mania: Effects on actigraphy-derived sleep parameters. J Sleep Res. 2020 Oct;29(5):e12984. doi: 10.1111/jsr.12984. Epub 2020 Jan 21.
PubMed 31967375Henriksen TE, Skrede S, Fasmer OB, Schoeyen H, Leskauskaite I, Bjorke-Bertheussen J, Assmus J, Hamre B, Gronli J, Lund A. Blue-blocking glasses as additive treatment for mania: a randomized placebo-controlled trial. Bipolar Disord. 2016 May;18(3):221-32. doi: 10.1111/bdi.12390.
PubMed 27226262
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue-blocking Glasses for Treating Evening Activation and Sleep Disorders in Child and Adolescent Psychiatry - a Pilot Trans-diagnostic Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07433491
- Acronym / sponsor ID
- BATCAT-pilot / 6130-6130
- Conditions
- Insomnia, Delayed Sleep Phase Disorder, Hyperarousal, Transdiagnostic Psychopathology, Child and Adolescent Psychiatry
- Keywords
- children, adolescents, child and adolescent psychiatry, insomnia, delayed sleep phase disorder, hyperarousal, sleep, hospital ward
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- University of Bergen, University of Oslo, University Hospital of North Norway, Helse Vest
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 25 Feb 2026 (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 problems and regulation difficulties are frequent in the child and adolescent psychiatry population. Insomnia and delayed sleep-wake phase disorders (DSPWD) are highly prevalent, and risk factors for developing more severe illness courses and chronic disorders. Pharmacological treatments of sleep disorders dominate even for the youngest patients but are unsupported by long-term data on outcome and side effects. The majority of non-pharmacological treatment options are composite and resource demanding. The investigators will examine the effects and feasibility of the isolated intervention of evening/night use of blue-blocking glasses/real darkness as adjunctive treatment for insomnia and delayed sleep phase disorder in inpatient and outpatient settings for children and adolecents.
Detailed description
The investigators will conduct a pilot study to examine the effect and feasibility of blue-blocking glasses as adjunctive treatment for insomnia and delayed sleep phase disorder in child and adolescent inpatients and outpatient settings. If the intervention and protocol are feasible and promising with regards to clinical and physiological effects, the study will provide a sound base for planning larger multicenter RCT's. Blue-blocking glasses are a minimal risk, low-cost intervention, and have potential to improve illness-course through improved sleep and healthier circadian function. The intervention may reduce the need for pharmacological treatment for sleep and circadian disorders and enhance coping strategies for the adolescents and their caregivers. Lastly, the pilot study will yield much needed data on light conditions (daylight and nightlight) in hospital environments for children and adolescents and may contribute to improved sleep conditions in hospital wards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot RCT and feasibility study
| Arm | Type | Receives |
|---|---|---|
| Blue-blocking glasses | Experimental | Device: Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phoneBlue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participant's mobile phone screen (%) + treatment as usual |
| Dark mode (mobile phone) | Active comparator | Other: ControlApplication of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participants' mobile phone screen (%) + treatment as usual |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 12-18 years, receiving health-care from child and adolescent mental health services at UPA University Hospital of North Norway, Tromsø or BUP Haugesund Hospital, Haugesund
- Current Insomnia or DSPD comorbid to one or several pychiatric symptom presentations or diagnoses
- Able and willing to provide written informed consent
- Participants aged 12-15,9 years also need consent from both parents/carers
- Able to comply with protocol
Key exclusion criteria (6 listed)
- Not able to comply with protocol for a required minimum of one night
- Blindness or severely reduced translucency of both eyes
- Known malformation or damage of optical tract blindness
- Use of melatonin all formulas that cannot be paused
- High risk for suicide or self-harm
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 glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phoneAlso: Virtual darkness, Orange glasses, Amber lenses, Blue-blocking light filtersBlue-blocking glasses and night mode on mobile phoneBlue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participant's mobile phone screen (%) + treatment as usual | Device | Blue-blocking glasses |
| ControlAlso: Dark mode, Night modeApplication of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on particpants's mobile phone screen (%) + Treatment as usual | Other | Dark mode (mobile phone) |
Primary outcome
Change form baseline in sleep onset latency (SOL) at 1 week
Time frame: From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.
Sleep onset latency (minutes) subjectively assessed in sleep diary and objectively assessed from actigraphy derived sleep parameters. Sleep onset latency describes how long it takes to fall asleep from the moment the person tries to fall asleep to sleep starts.
Change from baseline in overnight melatonin production at 1 week
Time frame: From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.
Quantity of melatonin metabolite 6-sulphatoxymelatonin (aMT6s) in the total overnight urine volume (µg).
9 secondary outcomes
Affektive Reactivity Index, relf reported (ARI-S)
Time frame: From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
Self-report Generalized Anxiety Disorder -7 (GAD-7)
Time frame: From baseline to after 7 days of intervention. For outpatients, ARI-S and ARI-P are also assessed after 14 days of intervention.
Patient Health Questionnaire (PHQ-9)
Time frame: From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
KID-SCREEN-10
Time frame: From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.
Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ)
Time frame: From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.
Bergen Insomnia Scale (BIS)
Time frame: From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.
Motor activity
Time frame: From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
BioPoint biosensor
Time frame: During first and 7th day of intervention (inpatients), during 7th and 14 days of intervention (outpatients) For all patients the outcomes will be compared to baseline assessments.
Affektive Reactivity Index, parent-reported (ARI-P)
Time frame: From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
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 18 Sep 2026.
- Background: PubMed 27322730Esaki Y, Kitajima T, Ito Y, Koike S, Nakao Y, Tsuchiya A, Hirose M, Iwata N. Wearing blue light-blocking glasses in the evening advances circadian rhythms in the patients with delayed sleep phase disorder: An open-label trial. Chronobiol Int. 2016;33(8):1037-44. doi: 10.1080/07420528.2016.1194289. Epub 2016 Jun 20.
- Background: PubMed 39642162Kallestad H, Langsrud K, Simpson MR, Vestergaard CL, Vethe D, Kjorstad K, Faaland P, Lydersen S, Morken G, Ulsaker-Janke I, Saksvik SB, Scott J. Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled trial. PLoS Med. 2024 Dec 6;21(12):e1004380. doi: 10.1371/journal.pmed.1004380. eCollection 2024 Dec.
- Background: PubMed 31967375Henriksen TEG, Gronli J, Assmus J, Fasmer OB, Schoeyen H, Leskauskaite I, Bjorke-Bertheussen J, Ytrehus K, Lund A. Blue-blocking glasses as additive treatment for mania: Effects on actigraphy-derived sleep parameters. J Sleep Res. 2020 Oct;29(5):e12984. doi: 10.1111/jsr.12984. Epub 2020 Jan 21.
- Background: PubMed 27226262Henriksen TE, Skrede S, Fasmer OB, Schoeyen H, Leskauskaite I, Bjorke-Bertheussen J, Assmus J, Hamre B, Gronli J, Lund A. Blue-blocking glasses as additive treatment for mania: a randomized placebo-controlled trial. Bipolar Disord. 2016 May;18(3):221-32. doi: 10.1111/bdi.12390.
- Individual participant dataSharing planned: Yes. Data from GENEActiv, Biopoint and LYS-devices may be shared for IPD meta-analyses.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Tone Elise G Henriksen, MD PhD principal investigator
Helse Fonna
2 sites 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 (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone in people with Insomnia and Delayed Sleep Phase Disorder, run by Helse Fonna at 2 sites in Norway.
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 6 inclusion and 6 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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. 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 Tone Elise G Henriksen, MD PhD (004753473240, tgjo@helse-fonna.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change form baseline in sleep onset latency (SOL) at 1 week (time frame: From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.). 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?
On the ClinicalTrials.gov record for NCT07433491, which also lists 4 linked publications.
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 18 Sep 2026.