Feasibility of Light Therapy for Fatigue N-of-1 Trials

Completed · Not applicable

Conditions studied: Fatigue

In brief

This Personalized Trial will test the feasibility and effectiveness of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified fatigue. Participant's initial levels of fatigue and other outcomes will be assessed in a baseline period 2 weeks in length. Participants will spend 12 weeks alternating between bright light therapy, dim light therapy, and usual care methods to treat their fatigue, while answering daily questions and wearing an activity tracker. After 14 weeks, participants will have the ability to share their opinions about the Personalized Trials platform. The investigators believe a Personalized Trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.

Key facts

Study ID

NCT04707846

Run by

Northwell Health

People needed

60

Starts

2021-01-20

Expected to finish

2022-01-31

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 - 59 years old of age
• Fluent in English
• Self reported fatigue results score > 12 on a modified PROMIS Fatigue Short Form 8a scale
• Able to participate in blue light therapy
• Owns and can regularly access a smartphone capable of receiving text messages
• Owns and can regularly access an e-mail account
• Lives in the United States

You may not qualify if…

• <18 years old or >60 years old
• Pregnant women
• Previous diagnosis of a serious mental health condition or psychiatric disorder, such as bipolar disorder
• Previous diagnosis of eye disease, such as cataracts, glaucoma, macular degeneration, Stargardt disease or family history of Stargardt disease, retinitis or retinopathy, or other retinal disorders
• Previous diagnosis of diabetes
• Previous eye surgery
• Sensitivity to light or use of medication causing sensitivity to light
• Epilepsy or a history of seizures
• Participation in shift work (evening/night shifts, early morning shifts, rotating shifts, etc.)

Where it is running

• Center for Personalized Health — New York, New York, United States

Full record on ClinicalTrials.gov

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