- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07834944
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Shadab Rahman, PhD, MPH
- Telefonnummer: 617-975-8709
- E-post: srahman8@bidmc.harvard.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Indoor light (~100 lux)
|
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. |
|
Aktiv komparator: Dim Light (~5 lux)
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wake After Sleep Onset
Tidsram: 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)
|
|
Number of lapses on the Psychomotor Vigilance Test
Tidsram: 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)
|
|
Karolinska Sleepiness Scale
Tidsram: Baseline and 2 weeks (end of intervention)
|
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)
|
|
Resting state stress visual analog scale
Tidsram: Baseline and 2 weeks (end of intervention)
|
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)
|
|
Change in cortisol
Tidsram: 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)
|
|
Multi-day learning curve composite score
Tidsram: 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
Tidsram: 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)
|
|
WHODAS 2.0 daily functioning score
Tidsram: 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)
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026P000461
- 2U54AG062322-06 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
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