ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-58
SponsorBeth Israel Deaconess Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

peri/postmenopausal females aged 45-65 years with nocturnal VMS

Disqualifiers

selected diagnosed sleep or psychiatric disorders, current treatment with hypnotics or antidepressants, use of systemic hormones, or nocturnal caregiving responsibilities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial Light at Night (ALAN) 100 lux

    Behavioral

    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.

  • Artificial Light at Night (ALAN) Dim Light

    Behavioral

    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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Indoor light (~100 lux)Experimental treatment 1 intervention
Group B: Dim Light (~5 lux)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Wake After Sleep Onset

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.

Time frame
Baseline and 2 weeks (end of intervention)
2

Number of lapses on the Psychomotor Vigilance Test

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.

Time frame
Baseline and 2 weeks (end of intervention)
3

Karolinska Sleepiness Scale

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).

Time frame
Baseline and 2 weeks (end of intervention)
4

Resting state stress visual analog scale

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

Time frame
Baseline and 2 weeks (end of intervention)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: