Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-02-13
2027-06-30
Brief Summary
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Detailed Description
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Hospital rooms for patients undergoing inpatient Autologous Stem Cell Transplant at the Mount Sinai Medical Center (MSMC) and at the Memorial Sloan Kettering Cancer Center (MSKCC)) will be retrofitted to install 1 of 2 lighting interventions, either circadian-effective (intervention) and circadian-ineffective (comparison) ambient light that may improve sleep.
1-2 weeks and no more than 2 months prior to transplant, participants will be given an Actiwatch, Daysimeter (personal light meter), sleep logs, questionnaires, and a urine collection kit to assess melatonin. One blood sample for cytokine analyses will be collected during one of the hospital visits prior to transplant. Blood draws are always done in the morning and always at a similar time for the same individual. The same outcomes (questionnaires, Actiwatch, Daysimeter, urine samples, blood samples) will be collected during transplant period and once, four weeks after engraftment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Circadian Effective Lighting (CEL)
The CEL will be performed in hospital sites over a 2-month period.
Circadian Effective Lighting
Participants will receive lighting with a spectrum of 300K, 500 lux to the eye level between 7:00am and 10:00am in the morning, and hospital lighting (\<100lux) during the afternoon between 10:00am and 6:00pm. In the evening this group of participants will receive lighting with a spectrum of 3000K, \<50lux at eye light level between 6:00PM and bedtime.
Circadian Ineffective Lighting (CIL)
The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.
Circadian Ineffective Lightning (CIL)
Participants will receive lower lighting levels in the morning (lighting with A spectrum of 300k, \<50lux to the eye level between 7:00am and 10:00am) and the same lighting levels throughout the rest of the day.
Interventions
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Circadian Effective Lighting
Participants will receive lighting with a spectrum of 300K, 500 lux to the eye level between 7:00am and 10:00am in the morning, and hospital lighting (\<100lux) during the afternoon between 10:00am and 6:00pm. In the evening this group of participants will receive lighting with a spectrum of 3000K, \<50lux at eye light level between 6:00PM and bedtime.
Circadian Ineffective Lightning (CIL)
Participants will receive lower lighting levels in the morning (lighting with A spectrum of 300k, \<50lux to the eye level between 7:00am and 10:00am) and the same lighting levels throughout the rest of the day.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
* 21years or older
* Able to provide informed consent.
* English-language proficient
Exclusion Criteria
* Pregnancy
* Eye diseases which limit the ability of light to be processed
* Secondary cancer diagnosis within the last 5 years
* Severe sleep disorders
* History of bipolar disorder or manic episodes
* Severe psychological impairment
* Previous use of light therapy
* Active infection including COVID-19 infection
21 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Mariana Figueiro
Professor, Director of Light and Health Research Center at Mount Sinai
Principal Investigators
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Mariana Figueiro, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn Schoool of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY-21-01146
Identifier Type: -
Identifier Source: org_study_id
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