ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
ROSA-B: Impact of Artificial Light at Night on Brain Health in Midlife Women With Vasomotor Symptom
This randomized, parallel-group study will examine how artificial light exposure during nighttime awakenings affects sleep and brain health in midlife women experiencing vasomotor symptoms, such as hot flashes and night sweats. Participants will be randomly assigned to exposure to either typical indoor-intensity light (approximately 100 lux) or dim light (less than 3 lux) during the night. The study will assess the effects of nighttime light exposure on sleep fragmentation, daytime alertness and sleepiness, stress responses, cognitive and emotional functioning, and daily functioning. It will also explore whether sleep fragmentation helps explain the effects of nighttime light exposure on stress and neuropsychological health. The findings may inform strategies to reduce nighttime light exposure and improve sleep and brain health in women during and after the menopause transition.
調査の概要
状態
条件
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：Shadab Rahman, PhD, MPH
- 電話番号：617-975-8709
- メール：srahman8@bidmc.harvard.edu
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:
- peri/postmenopausal females aged 45-65 years with nocturnal VMS
Exclusion Criteria:
- selected diagnosed sleep or psychiatric disorders, current treatment with hypnotics or antidepressants, use of systemic hormones, or nocturnal caregiving responsibilities
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：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
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：Indoor light (~100 lux)
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Participants will be exposed to a controlled artificial-light-at-night condition during the scheduled overnight sleep episode. Light will be delivered using a standardized light source at a predetermined intensity and timing to examine its effects on sleep, brain health, and related physiological outcomes in midlife women with vasomotor symptoms. |
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アクティブコンパレータ：Dim Light (~5 lux)
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Participants will be exposed to a controlled dim-light condition of approximately 5 lux during the scheduled overnight sleep episode. This condition will serve as the comparator for the artificial-light-at-night condition of approximately 100 lux. |
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 |
|---|---|---|
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Wake After Sleep Onset
時間枠：Baseline and 2 weeks (end of intervention)
|
Wake After Sleep Onset (WASO) is a measure of sleep fragmentation. Participants complete a daily diary each morning for a week where they report how many minutes they think they were awake the previous night after first falling asleep. Nightly WASO collected over 1 week immediately preceding each timepoint are averaged. Higher WASO indicates more sleep disruption. |
Baseline and 2 weeks (end of intervention)
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Number of lapses on the Psychomotor Vigilance Test
時間枠：Baseline and 2 weeks (end of intervention)
|
Number of lapses recorded during the 10-minute Psychomotor Vigilance Test (PVT) is a measure of neurobehavioral alertness. A lapse on the PVT is a response to stimulus >500 msec. A higher number of lapses indicates lower vigilance and greater neurobehavioral impairment. |
Baseline and 2 weeks (end of intervention)
|
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Karolinska Sleepiness Scale
時間枠：Baseline and 2 weeks (end of intervention)
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The Karolinska Sleepiness Scale (KSS) is a measure of self-reported sleepiness, a one-item scale from 1 (very alert) to 9 (sleepy; great effort to keep awake). |
Baseline and 2 weeks (end of intervention)
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Resting state stress visual analog scale
時間枠：Baseline and 2 weeks (end of intervention)
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Self-reported resting state stress is measured using a one-item visual analog scale (VAS) from 0 (Stressed Out) to 100 (Calm/Relaxed). Participants answer the resting state stress VAS each morning upon wake. Daily scores collected over 1 week immediately preceding each timepoint are averaged |
Baseline and 2 weeks (end of intervention)
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Change in cortisol
時間枠：2 weeks (end of intervention)
|
Change in cortisol before and after a 20-minute stress task is measured using salivary biosamples. |
2 weeks (end of intervention)
|
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Multi-day learning curve composite score
時間枠：2 weeks (end of intervention)
|
Cognitive function is measured with a multi-day learning curve composite score based on a cognitive assessment that participants complete daily over 1 week preceding the timepoint. The composite score ranges from 0 (no learning) to 1 (optimal learning). |
2 weeks (end of intervention)
|
|
Patient-Reported Outcomes Measurement Information System-Depression Scale
時間枠：Baseline and 2 weeks (end of intervention)
|
The Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS-D) is a self-report short-form to assess depressive symptoms. A higher score indicates more depressive symptoms. |
Baseline and 2 weeks (end of intervention)
|
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WHODAS 2.0 daily functioning score
時間枠：Baseline and 2 weeks (end of intervention)
|
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a 36-item self-report questionnaire to assess daily functioning. The score ranges from 0 (no disability) to 100 (full disability). |
Baseline and 2 weeks (end of intervention)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2026P000461
- 2U54AG062322-06 (米国 NIH グラント/契約)
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
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