Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorHelse Fonna

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone

    Device

    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

  • Control

    Other intervention

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Blue-blocking glassesExperimental treatment 1 intervention
Group B: Dark mode (mobile phone)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Quantity of melatonin metabolite 6-sulphatoxymelatonin (aMT6s) in the total overnight urine volume (µg).

Time frame
From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.

Secondary outcomes

1

Affektive Reactivity Index, relf reported (ARI-S)

Self-report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome.

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.
2

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.

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.
3

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.

Time frame
From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
4

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.

Time frame
From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helse Fonna

Lead sponsor

University of Bergen

Collaborator

University of Oslo

Collaborator

University Hospital of North Norway

Collaborator

Helse Vest

Collaborator