Recruiting

Ambient Light

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05737732

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Circadian Effective Lighting

Circadian Ineffective Lightning (CIL)

Study Details

Brief summary:

The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, Inflammation, Neutropenic Fever and Symptom Burden among Multiple Myeloma Patients undergoing Autologous Stem Cell Transplantation. To achieve this aim, 200 multiple myeloma patients will receive one of two different light-treatments that are designed to promote circadian rhythm alignment. While receiving these light treatments, participants' sleep efficiency, urine melatonin levels, blood inflammatory cytokine levels and symptoms will be assessed over a 2-month period.

Conditions

Multiple Myeloma

Study ID

NCT05737732

Start date

Feb 13, 2023

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Multiple Myeloma diagnosis
  • Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
  • 21years or older
  • Able to provide informed consent.
  • English-language proficient

Exclusion Criteria:

  • Previous Autologous Stem Cell Transplant procedure
  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Circadian Effective Lighting (CEL)

The CEL will be performed in hospital sites over a 2-month period.

sham comparator: Circadian Ineffective Lighting (CIL)

The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.

Interventions

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.

Primary outcome measure

  • Changes in Urinary Melatonin [ Time Frame: Baseline visit and 3 days after the Autologous Stem Cell Transplant ]

Central Contacts and Locations

Central contacts

Barbara Plitnick, BSN

518 242-4603Barbara.Plitnick@mountsinai.org

Mariana Figueiro, PhD

518-366-9306Mariana.Figueiro@mountsinai.org

Locations

Icahn Schoool of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Mariana Figueiro, PhD

518-366-9306mariana.figueiro@mountsinai.org

Barbara Plitnick, BSN

518-242-4603Barbara.Plitnick@mountsinai.org

Principal Investigator:

Mariana Figueiro

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Sergio Giralt, MD

giralts@mskcc.org

Principal Investigator:

Sergio Giralt

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-12.