Feasibility of Light Therapy for Fatigue N-of-1 Trials
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Bright Blue Light Commercial AYO Light Therapy Device; Dim Blue Light Commercial AYO Light Therapy Device
Intervention type(s): Device; Device
Intervention description(s): 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).; 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).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: N-of-1; Fatigue; Virtual; Personalized Trial; Personalized; Feasibility; Light Therapy; Dim Light Therapy; Bright Light Therapy