Women in the Menopausal PeriodNCT07834944
ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
A study testing Artificial Light at Night (ALAN) 100 lux and Artificial Light at Night (ALAN) Dim Light in people with Women in the Menopausal Period, run by Beth Israel Deaconess Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women in the Menopausal Period
- What is being tested?
- Artificial Light at Night (ALAN) 100 lux and Artificial Light at Night (ALAN) Dim Light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- peri/postmenopausal females aged 45-65 years with nocturnal VMS
Who cannot join
- selected diagnosed sleep or psychiatric disorders, current treatment with hypnotics or antidepressants, use of systemic hormones, or nocturnal caregiving responsibilities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Women in the Menopausal Period
- Being tested
- Artificial Light at Night (ALAN) 100 lux, Artificial Light at Night (ALAN) Dim Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Light at Night (ALAN) 100 luxBehavioural
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 LightBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Indoor light (~100 lux) | Experimental | Not described Receives: Behavioral: Artificial Light at Night (ALAN) 100 lux |
| Dim Light (~5 lux) | Active comparator | Not described Receives: Behavioral: Artificial Light at Night (ALAN) Dim Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2 weeks (end of intervention)
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.
Measured: Baseline and 2 weeks (end of intervention)
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).
Measured: Baseline and 2 weeks (end of intervention)
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
Measured: Baseline and 2 weeks (end of intervention)
Change in cortisol
Change in cortisol before and after a 20-minute stress task is measured using salivary biosamples.
Measured: 2 weeks (end of intervention)
Multi-day learning curve composite score
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).
Measured: 2 weeks (end of intervention)
Patient-Reported Outcomes Measurement Information System-Depression Scale
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.
Measured: Baseline and 2 weeks (end of intervention)
WHODAS 2.0 daily functioning score
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).
Measured: Baseline and 2 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women in the Menopausal PeriodStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shadab Rahman, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834944
- Sponsor's protocol ID
- 2026P000461
- Other IDs
- 2U54AG062322-06
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSA-B: Impact of Artificial Light at Night on Brain Health in Midlife Women With Vasomotor Symptom
- ClinicalTrials.gov ID
- NCT07834944
- Acronym / sponsor ID
- 2026P000461
- Conditions
- Women in the Menopausal Period
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indoor light (~100 lux) | Experimental | Behavioral: Artificial Light at Night (ALAN) 100 lux |
| Dim Light (~5 lux) | Active comparator | Behavioral: Artificial Light at Night (ALAN) Dim Light |
Who may qualify
- Ages
- 45 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- peri/postmenopausal females aged 45-65 years with nocturnal VMS
Key exclusion criteria (1 listed)
- selected diagnosed sleep or psychiatric disorders, current treatment with hypnotics or antidepressants, use of systemic hormones, or nocturnal caregiving responsibilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Light at Night (ALAN) 100 luxParticipants 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. | Behavioural | Indoor light (~100 lux) |
| Artificial Light at Night (ALAN) Dim LightParticipants 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. | Behavioural | Dim Light (~5 lux) |
Primary outcome
Wake After Sleep Onset
Time frame: 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.
Number of lapses on the Psychomotor Vigilance Test
Time frame: 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.
Karolinska Sleepiness Scale
Time frame: 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).
Resting state stress visual analog scale
Time frame: 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
Change in cortisol
Time frame: 2 weeks (end of intervention)
Change in cortisol before and after a 20-minute stress task is measured using salivary biosamples.
Multi-day learning curve composite score
Time frame: 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).
Patient-Reported Outcomes Measurement Information System-Depression Scale
Time frame: 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.
WHODAS 2.0 daily functioning score
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Related trials for Women in the Menopausal Period
RecruitingPhase 4
A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures
Osteoporosis in Post-menopausal Women
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Light at Night (ALAN) 100 lux and Artificial Light at Night (ALAN) Dim Light in people with Women in the Menopausal Period, run by Beth Israel Deaconess Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shadab Rahman, PhD, MPH (617-975-8709, srahman8@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake After Sleep Onset (time frame: Baseline and 2 weeks (end of intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.