소아 및 청소년 정신의학에서 수면 장애를 위한 블루라이트 차단 안경 (BATCAT-pilot)
아동 및 청소년 정신의학에서 저녁 시간 과활성화 및 수면 장애 치료를 위한 블루라이트 차단 안경 - 예비 진단 간 무작위 대조 시험.
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Tone Elise G Henriksen, MD PhD
- 전화번호: 004753473240
- 이메일: tgjo@helse-fonna.no
연구 연락처 백업
- 이름: Marit Nymoen, PhD
- 전화번호: 0052732805
- 이메일: marit.nymoen@helse-fonna.no
연구 장소
-
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Rogaland
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Haugesund, Rogaland, 노르웨이, 5520
- 모병
- BUP Haugesund
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연락하다:
- Sigrund Drivenes, MSc
- 전화번호: 004752732805
- 이메일: sigrund.drivenes@helse-fonna.no
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연락하다:
- Georg W Reinhardt, MD
- 전화번호: 004752732805
- 이메일: georg.walter.reinhardt@helse-fonna.no
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Troms
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Tromsø, Troms, 노르웨이, 9019
- 아직 모집하지 않음
- BUPA Tromsø, The University Hospital of North Norway
-
연락하다:
- Christian Eckhoff, MD, PhD
- 전화번호: +47 +47761700700
- 이메일: christian.eckhoff@uit.no
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연락하다:
- Judeson Joseph, MD
- 전화번호: +47 +4776170700
- 이메일: judeson.joseph@unn.no
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Blue-blocking glasses
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 |
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
다른 이름들:
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활성 비교기: Dark mode (mobile phone)
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 |
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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change form baseline in sleep onset latency (SOL) at 1 week
기간: 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. |
From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.
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Change from baseline in overnight melatonin production at 1 week
기간: From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.
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Quantity of melatonin metabolite 6-sulphatoxymelatonin (aMT6s) in the total overnight urine volume (µg). |
From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Affektive Reactivity Index, relf reported (ARI-S)
기간: From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
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Self-report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome. |
From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
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Self-report Generalized Anxiety Disorder -7 (GAD-7)
기간: 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. |
From baseline to after 7 days of intervention. For outpatients, ARI-S and ARI-P are also assessed after 14 days of intervention.
|
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Patient Health Questionnaire (PHQ-9)
기간: From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
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PHQ-9 is a nine-item self-report questionnaire rating depressive symptoms, minimum value 9, maximum value 36, high score indicate worse outcome. |
From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
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KID-SCREEN-10
기간: From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.
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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. |
From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.
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Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ)
기간: 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"). |
From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.
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Bergen Insomnia Scale (BIS)
기간: 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. |
From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.
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Motor activity
기간: From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
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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)
|
From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
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BioPoint biosensor
기간: 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 |
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)
기간: 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. |
From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Tone Elise G Henriksen, MD PhD, Helse Fonna
간행물 및 유용한 링크
일반 간행물
- 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.
- Kallestad 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.
- Henriksen 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.
- Henriksen 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 6130-6130
- F-12812 (기타 보조금/기금 번호: Helse Vest Research Grant)
- 593439 (기타 식별자: Regional Committees for Medical and Health Research Ethics)
- 764677 (기타 식별자: SIKT)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Data from GENEActiv, Biopoint and LYS-devices may be shared for IPD meta-analyses.
IPD 공유 액세스 기준
IPD will be shared with other researchers upon reasonable request to the principal investigator.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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