Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)

NACompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

September 1, 2015

Primary Completion Date

April 1, 2022

Study Completion Date

April 1, 2022

Conditions
Multiple MyelomaFatigue
Interventions
DEVICE

AYO light glasses (Experimental)

The AYO does not contain UV or infra-red light; the light spectrum begins at approximately 420nm. The circadian-effective AYO is programed at over 100 lux with 470nm frequency and irradiance of 250 qW/cm2, which is 100% intensity level. Irradiance over lux itself with AYO light glasses is believed to be more representative due to light frequency and proximity to the eye. Traditional Lightbox usual measure is Lux , AYO can be seen as comparable to 1,000 lux light box. The device is classified as a device that is safe for the eyes in accordance with the international standard IEC 62471 and is independently certified by TÜV Rheinland. AYO complies with the EU's CE marking (CE EMC EN 55014, EN 61000-4-3) as well as other national regulatory directives. AYO also complies with the United States of America's FCC marking (FCC Title 47, Chapter 1, Part 15, Class B FCC VOC: 47 CFR PART 15 OCT, 2016. CLASS B ANSI C 63.4: 2014) as well as other national marking regulatory directives.

DEVICE

AYO light glasses (Comparator)

The comparison group will wear the same AYO glasses, but with a circadian ineffective (sham) light. The circadian-ineffective (sham) is programed at 1% intensity, therefore according to our calculation and checks it is below circadian threshold of 2 lux as specified.

Trial Locations (3)

10029

Icahn School of Medicine at Mount Sinai, New York

10065

Memorial Sloan Kettering Cancer Center, New York

07601

Hackensack University Medical Center, Hackensack

All Listed Sponsors
collaborator

Memorial Sloan Kettering Cancer Center

OTHER

collaborator

Hackensack Meridian Health

OTHER

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT03119363 - Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study) | Biotech Hunter | Biotech Hunter