Child and Adolescent Psychiatry, Delayed Sleep Phase Disorder, Hyperarousal, Insomnia, Transdiagnostic Psychopathology
Conditions
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, inpatients
Brief 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.
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.
Interventions
DEVICEBlue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone
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
OTHERControl
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
Sponsors
Helse Fonna
University of Bergen
University of Oslo
University Hospital of North Norway
Helse Vest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The persons performing the statistical analyses will be blinded for the group allocation of the participants.
Intervention model description
Pilot RCT and feasibility study
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change form baseline in sleep onset latency (SOL) at 1 week | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Affektive Reactivity Index, relf reported (ARI-S) | 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 form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome. |
| Self-report Generalized Anxiety Disorder -7 (GAD-7) | From baseline to after 7 days of intervention. For outpatients, ARI-S and ARI-P are also assessed after 14 days of intervention. | 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. |
| Patient Health Questionnaire (PHQ-9) | From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention. | PHQ-9 is a nine-item self-report questionnaire rating depressive symptoms, minimum value 9, maximum value 36, high score indicate worse outcome. |
| KID-SCREEN-10 | From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention. | 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. |
| Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ) | From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention. | 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"). |
| Bergen Insomnia Scale (BIS) | From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention. | 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. |
| Motor activity | From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention. | 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) |
| BioPoint biosensor | 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. | The BioPoint sensor is a physiological multisensor worn as a watch measuring heart rate, heart rate variability, peripheral skin impedance, peripheral temperature |
| Affektive Reactivity Index, parent-reported (ARI-P) | From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention. | Proxy (care-giver) report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome. |
Countries
Norway
Contacts
CONTACTTone Elise G Henriksen, MD PhD
CONTACTMarit Nymoen, PhD
PRINCIPAL_INVESTIGATORTone Elise G Henriksen, MD PhD
Helse Fonna
Outcome results
None listed