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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Smart Light Therapy Glasses for Sleep and Mental Wellness

NCT07168954

Depression Sleep Disturbance

COMPLETED NA

Bright Light Therapy in ME/CFS Patients

NCT06635928

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

COMPLETED NA

Bright Light Therapy for Post-COVID-19 Fatigue

NCT05677932

Post COVID-19 Condition

UNKNOWN NA

The Efficacy of Using Far Infrared Radiation to Manage Muscular Dystrophies

NCT00674843

Muscular Dystrophies

UNKNOWN PHASE1

Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis

NCT00375544

Osteoarthritis, Knee

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This Personalized Trial will test the feasibility of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified fatigue. Symptoms of fatigue will be defined using the PROMIS Fatigue measures. Following a 2 week baseline assessment period, participants will be randomized in a multiple crossover design to receive bright blue light therapy, dim blue light therapy, and usual care in 6 treatment periods 2 weeks in length (12 weeks total). Participants will be randomly assigned to 2 groups receiving treatments in different order. Group 1 will receive treatments in the following order: bright light, dim light, usual care, usual care, dim light, bright light. Group 2 will receive treatments in the following order: usual care, dim light, bright light, bright light, dim light, usual care. Light therapy will be delivered using commercial available devices manufactured by AYO. The total duration of the study will be 14 weeks. During the baseline assessments and all treatment periods, participants will be assessed using daily survey measures, weekly survey measures, ecological momentary assessment (EMA) measures delivered via text message 3 times daily, and information collected via a Fitbit device. Survey measures will assess participant self-reported fatigue. EMA measures will ask participants to rate their fatigue, pain, concentration, confidence, mood, and stress in the moment. Participant daily steps and nightly sleep duration will be assessed using the Fitbit Charge 3™ device. After at the end of the study, participants will receive a personalized report summarizing their data from the baseline assessment and from each treatment period. Participants will be asked to evaluate their experience with the Personalized N-of-1 Trial overall and each element of the trial using the System Usability Scale (SUS) as well as a satisfaction survey measure. Participant adherence to study intervention devices (e.g. AYO bright blue light and AYO dim blue light machines), survey measures, EMA measures, and Fitbit device usage will also be assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bright Light Therapy

Individuals will receive bright blue light therapy using glasses developed by AYO. During treatment blocks for bright blue light therapy, participants will receive a text message within an hour of their self-reported wake time instructing them to use their designated light therapy device for 30 minutes. Bright blue light therapy will be administered in 2 treatment periods each 2 weeks in length (4 weeks total). Bright blue light treatment has been previously identified as an efficacious treatment for fatigue. It has also been shown in a number of studies that the blue wavelength of light is a key component to the shift of fatigue measures in patient reported outcomes.

Group Type EXPERIMENTAL

Bright Blue Light Commercial AYO Light Therapy Device

Intervention Type DEVICE

AYO light therapy glasses are a commercially available device which have 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm ± 2nm and typical irradiance (100% intensity) of approximately 250 µW/cm². AYO bright light glasses are classified as "exempt" for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471).

Dim Light Therapy

Individuals will receive dim blue light therapy using glasses developed by AYO. During treatment blocks for bright blue light therapy, participants will receive a text message within an hour of their self-reported wake time instructing them to use their designated light therapy device for 30 minutes. Dim blue light therapy will be administered in 2 treatment periods each 2 weeks in length (4 weeks total).

Group Type ACTIVE_COMPARATOR

Dim Blue Light Commercial AYO Light Therapy Device

Intervention Type DEVICE

AYO light therapy glasses were made available to the research team by the vendor. The device has 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm ± 2nm and reduced irradiance (1% intensity) of approximately 250 µW/cm². AYO dim light glasses are classified as "exempt" for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471).

Usual Care

During usual care periods, participants will be instructed to abstain from use of AYO light therapy devices, and instructed to treat their fatigue as they normally would. Usual care will be presented in 2 periods each 2 weeks in length (4 weeks total).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bright Blue Light Commercial AYO Light Therapy Device

AYO light therapy glasses are a commercially available device which have 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm ± 2nm and typical irradiance (100% intensity) of approximately 250 µW/cm². AYO bright light glasses are classified as "exempt" for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471).

Intervention Type DEVICE

Dim Blue Light Commercial AYO Light Therapy Device

AYO light therapy glasses were made available to the research team by the vendor. The device has 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm ± 2nm and reduced irradiance (1% intensity) of approximately 250 µW/cm². AYO dim light glasses are classified as "exempt" for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* \<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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes