N/A
N=60
Feasibility of Light Therapy for Fatigue N-of-1 Trials
Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT04707846 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Mean System Usability Score (SUS). — 78.89 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bright Blue Light Commercial AYO Light Therapy Device (Device); Dim Blue Light Commercial AYO Light Therapy Device (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean System Usability Score (SUS). |
78.89 | — |
| SECONDARY Within-Subject Difference in Self-reported Daily Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 7b Daily |
— | — |
| SECONDARY Within-Subject Difference in Self-reported Weekly Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 8a. |
— | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue. |
— | — |
| SECONDARY Participant Satisfaction With Personalized Trial Components. |
— | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain. |
— | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration. |
— | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence. |
— | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood. |
— | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress. |
— | — |
| SECONDARY Within-Subject Difference in Fitbit Device-Recorded Daily Steps. |
— | — |
| SECONDARY Within-Subject Difference in Fitbit Device-Recorded Sleep Duration. |
— | — |
| SECONDARY Mean Participant Survey Adherence Rate. |
— | — |
| SECONDARY Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate. |
— | — |
| SECONDARY Mean Fitbit Device Adherence Rate. |
— | — |
| SECONDARY Mean Participant Adherence to AYO Bright Blue Light Device. |
— | — |
| SECONDARY Mean Participant Adherence to AYO Dim Blue Light Device. |
— | — |
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.
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
- 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.)
Data sourced from ClinicalTrials.gov (NCT04707846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.