小児・思春期精神医学における睡眠障害のためのブルーブロッキングメガネ (BATCAT-pilot)
小児・青年期精神医学における夕方の活性化と睡眠障害の治療のためのブルーブロッキング眼鏡 - パイロットトランス診断ランダム化比較試験。
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tone Elise G Henriksen, MD PhD
- 電話番号：004753473240
- メール：tgjo@helse-fonna.no
研究連絡先のバックアップ
- 名前：Marit Nymoen, PhD
- 電話番号：0052732805
- メール：marit.nymoen@helse-fonna.no
研究場所
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Rogaland
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Haugesund、Rogaland、ノルウェー、5520
- 募集
- BUP Haugesund
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コンタクト：
- Sigrund Drivenes, MSc
- 電話番号：004752732805
- メール：sigrund.drivenes@helse-fonna.no
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コンタクト：
- Georg W Reinhardt, MD
- 電話番号：004752732805
- メール：georg.walter.reinhardt@helse-fonna.no
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Troms
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Tromsø、Troms、ノルウェー、9019
- まだ募集していません
- BUPA Tromsø, The University Hospital of North Norway
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コンタクト：
- Christian Eckhoff, MD, PhD
- 電話番号：+47 +47761700700
- メール：christian.eckhoff@uit.no
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コンタクト：
- Judeson Joseph, MD
- 電話番号：+47 +4776170700
- メール：judeson.joseph@unn.no
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
他の名前：
|
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アクティブコンパレータ：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change form baseline in sleep onset latency (SOL) at 1 week
時間枠：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.
|
|
Change from baseline in overnight melatonin production at 1 week
時間枠：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). |
From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Affektive Reactivity Index, relf reported (ARI-S)
時間枠：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. |
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)
時間枠：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.
|
|
Patient Health Questionnaire (PHQ-9)
時間枠：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. |
From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
|
|
KID-SCREEN-10
時間枠：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)
時間枠：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.
|
|
Bergen Insomnia Scale (BIS)
時間枠：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
時間枠：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)
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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
時間枠：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)
時間枠：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.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Tone Elise G Henriksen, MD PhD、Helse Fonna
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 6130-6130
- F-12812 (その他の助成金/資金番号：Helse Vest Research Grant)
- 593439 (その他の識別子：Regional Committees for Medical and Health Research Ethics)
- 764677 (その他の識別子：SIKT)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data from GENEActiv, Biopoint and LYS-devices may be shared for IPD meta-analyses.
IPD 共有アクセス基準
IPD will be shared with other researchers upon reasonable request to the principal investigator.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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