Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry (NCT07433491) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry
Norway40 participantsStarted 2026-02-01
Plain-language 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. 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change form baseline in sleep onset latency (SOL) at 1 week
Timeframe: From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.
2
Change from baseline in overnight melatonin production at 1 week
Timeframe: From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.