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

NCT04707846 | Completed Results DMC

• 2 other identifiers: 20-0835R01LM012836
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

N-of-1; Fatigue; Virtual; Personalized Trial; Personalized; Feasibility; Light Therapy; Dim Light Therapy; Bright Light Therapy

Outcome Measures

Primary Outcomes (1)

• Mean System Usability Score (SUS).

  The SUS is a validated 10-item questionnaire that asks users to score each item on a Likert scale from Strongly Disagree (rating of 1) to Strongly Agree (rating of 5). The SUS will be presented to the participant as addressing the ease of use, complexity, consistency of the Personalized Trials system as a whole, from recruitment to receipt of the report. Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together and an overall mean will be reported with standard deviation. Higher scored values correlate to a more usable system, and therefore a better outcome.

  Assessed once after the results report has been sent to the participant, within 4 months of intervention completion.

Secondary Outcomes (16)

• Within-Subject Difference in Self-reported Daily Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 7b Daily

  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).

• Within-Subject Difference in Self-reported Weekly Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 8a.

  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).

• Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.

  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).

• Participant Satisfaction With Personalized Trial Components.

  Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.

• Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.

  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).

Other Outcomes (1)

• Within-Subject Difference in Self-Reported Side Effects.

  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).

Study Arms (3)

Bright Light Therapy

EXPERIMENTAL

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.

Device: Bright Blue Light Commercial AYO Light Therapy Device

Dim Light Therapy

ACTIVE COMPARATOR

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).

Device: Dim Blue Light Commercial AYO Light Therapy Device

Usual Care

NO INTERVENTION

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).

Interventions

Bright Blue Light Commercial AYO Light Therapy Device 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).

Bright Light Therapy

Dim Blue Light Commercial AYO Light Therapy Device 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).

Dim Light Therapy

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.)

Sponsors & Collaborators

• Northwell Health: lead
• Columbia University: collaborator
• National Library of Medicine (NLM): collaborator

Study Sites (1)

Center for Personalized Health

New York, New York, 10022, United States

Location

Related Publications (8)

• National Institutes of Health (2007). PROMIS domain framework definitions. http://www.nihpr omis.org/measu res/domai nframework .

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30296404 BACKGROUND

• 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.

  PMID: 26122037 BACKGROUND

• 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.

  PMID: 29477098 BACKGROUND

• 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.

  BACKGROUND

• Butler M, D'Angelo S, Ahn H, Chandereng T, Miller D, Perrin A, Romain AN, Scatoni A, Friel CP, Cheung YK, Davidson KW. A Series of Personalized Virtual Light Therapy Interventions for Fatigue: Feasibility Randomized Crossover Trial for N-of-1 Treatment. JMIR Form Res. 2023 Sep 18;7:e45510. doi: 10.2196/45510.

  PMID: 37721795 DERIVED

• 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.

  PMID: 36283748 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joan Duer-Hefele, RN, MA
• Organization: Northwell Health

jduerhefele@northwell.edu

646-766-7153

Study Officials

• Karina Davidson, MASc, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 13, 2021
• Study Start: January 20, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form before the first participants randomized into the study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
• Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.

Locations

US (1)