Clinical trial NCT04707846: Feasibility of Light Therapy for Fatigue N-of-1 Trials
Official title: Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials of Light Therapy for Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: N-of-1
Fatigue
Virtual
Personalized Trial
Personalized
Feasibility
Light Therapy
Dim Light Therapy
Bright Light Therapy
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Columbia University
name: National Library of Medicine (NLM)
First posted: 2021-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Mean System Usability Score (SUS).
timeFrame: Assessed once after the results report has been sent to the participant, within 4 months of intervention completion.
Secondary outcomes:
measure: Within-Subject Difference in Self-reported Daily Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 7b Daily
timeFrame: Daily fatigue will be assessed daily via survey during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each).
measure: Within-Subject Difference in Self-reported Weekly Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 8a.
timeFrame: Weekly fatigue will be assessed weekly via survey during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.
timeFrame: EMA fatigue will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Participant Satisfaction With Personalized Trial Components.
timeFrame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.
timeFrame: EMA pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.
timeFrame: EMA concentration will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.
timeFrame: EMA confidence will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.
timeFrame: EMA mood will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.
timeFrame: EMA stress will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Within-Subject Difference in Fitbit Device-Recorded Daily Steps.
timeFrame: Daily steps will be assessed consistently via Fitbit Charge 3™ device during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Within-Subject Difference in Fitbit Device-Recorded Sleep Duration.
timeFrame: Nightly sleep duration will be assessed consistently via Fitbit Charge 3™ device during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
measure: Mean Participant Survey Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
measure: Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
measure: Mean Fitbit Device Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
measure: Mean Participant Adherence to AYO Bright Blue Light Device.
timeFrame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
measure: Mean Participant Adherence to AYO Dim Blue Light Device.
timeFrame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Other outcomes:
measure: Within-Subject Difference in Self-Reported Side Effects.
timeFrame: Self-reported side effects will be assessed via weekly survey during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).
Locations:
city: New York
country: United States
facility: Center for Personalized Health
state: New York
Study officials:
affiliation: Northwell Health
name: Karina Davidson, MASc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Institutes of Health (2007). PROMIS domain framework definitions. http://www.nihpr omis.org/measu res/domai nframework .
citation: Brooke, J (1996). SUS: A "quick and dirty" usability scale. In P. Jordan, B. Thomas, & B. Weerdmeester (Eds.), Usability evaluation in industry (pp. 189-194). London, UK: Taylor & Francis.
citation: Hanifin JP, Lockley SW, Cecil K, West K, Jablonski M, Warfield B, James M, Ayers M, Byrne B, Gerner E, Pineda C, Rollag M, Brainard GC. Randomized trial of polychromatic blue-enriched light for circadian phase shifting, melatonin suppression, and alerting responses. Physiol Behav. 2019 Jan 1;198:57-66. doi: 10.1016/j.physbeh.2018.10.004. Epub 2018 Oct 5.
citation: Sasseville A, Martin JS, Houle J, Hebert M. Investigating the contribution of short wavelengths in the alerting effect of bright light. Physiol Behav. 2015 Nov 1;151:81-7. doi: 10.1016/j.physbeh.2015.06.028. Epub 2015 Jun 27.
citation: Meesters Y, Duijzer WB, Hommes V. The effects of low-intensity narrow-band blue-light treatment compared to bright white-light treatment in seasonal affective disorder. J Affect Disord. 2018 May;232:48-51. doi: 10.1016/j.jad.2018.01.024. Epub 2018 Feb 22.
citation: Smolders KC, Kort YAD. Bright light and mental fatigue: Effects on alertness, vitality, performance and physiological arousal. Journal of Environmental Psychology. 2014;39:77-91. doi:10.1016/j.jenvp.2013.12.010.
citation: Butler M, D'Angelo S, Lewis C, Miller D, Perrin A, Suls J, Chandereng T, Cheung YK, Davidson KW. Series of virtual light therapy interventions for fatigue: a feasibility pilot study protocol for a series of personalised (N-of-1) trials. BMJ Open. 2022 Oct 25;12(10):e055518. doi: 10.1136/bmjopen-2021-055518.