FatigueNCT04707846
Feasibility of Light Therapy for Fatigue N-of-1 Trials
A study testing Bright Blue Light Commercial AYO Light Therapy Device and Dim Blue Light Commercial AYO Light Therapy Device in people with Fatigue, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Bright Blue Light Commercial AYO Light Therapy Device and Dim Blue Light Commercial AYO Light Therapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- <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
Show all 9Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Personalized Health
New York, New York, 10022
About this study
Official title: Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials of Light Therapy for Fatigue
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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Bright Blue Light Commercial AYO Light Therapy Device, Dim Blue Light Commercial AYO Light Therapy Device
- Keywords
- N-of-1, Fatigue, Virtual, Personalized Trial, Personalized, Feasibility, Light Therapy, Dim Light Therapy, Bright Light Therapy
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Blue Light Commercial AYO Light Therapy DeviceDevice
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 Blue Light Commercial AYO Light Therapy DeviceDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
All Daily Fatigue items are rated on a scale of 1 to 5, with higher scores indicating higher levels of fatigue. PROMIS Daily Fatigue scale scores will be converted to T-scores using methods from the PROMIS scoring manual based on item response theory. Levels of daily fatigue will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of fatigue will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in daily fatigue over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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.
All Weekly Fatigue items are rated on a scale of 1 to 5, with higher scores indicating higher levels of fatigue. PROMIS Weekly Fatigue scale scores will be converted to T-scores using methods from the PROMIS scoring manual based on item response theory. Levels of weekly fatigue will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of weekly fatigue will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in weekly fatigue over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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.
Fatigue will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their fatigue on a scale of 0(low) to 10(high). Levels of EMA fatigue will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA fatigue will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA fatigue over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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.
Participants will rate their satisfaction with the Personalized N-of-1 Trial overall and with individual elements of the trial in a satisfaction survey administered following the baseline and treatment periods (14 weeks). Satisfaction items are not part of an already existing scale but were developed to assess participant satisfaction with specific elements of the current study and the personalized trial overall. Participants will rate their satisfaction on a scale of 1 to 5, with higher numbers indicating greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.
Measured: 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.
Pain will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their pain on a scale of 0(low) to 10(high). Levels of EMA pain will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA pain will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA pain over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.
Concentration will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their concentration on a scale of 0(low) to 10(high). Levels of EMA concentration will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA concentration will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA concentration over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.
Confidence will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their confidence on a scale of 0(low) to 10(high). Levels of EMA confidence will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA confidence will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA confidence over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.
Mood will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their mood on a scale of 0(poor) to 10(excellent). Levels of EMA mood will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA mood will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA mood over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.
Stress will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their stress on a scale of 0(low) to 10(high). Levels of EMA stress will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA stress will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA stress over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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).
Within-Subject Difference in Fitbit Device-Recorded Daily Steps.
Daily step counts will be assessed by a Fitbit Charge 3™ device. Daily step counts will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean daily steps will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Daily steps values over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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).
Within-Subject Difference in Fitbit Device-Recorded Sleep Duration.
Nightly sleep duration will be assessed by a Fitbit Charge 3™ device. Sleep duration will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean sleep duration will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Sleep duration values over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
Measured: 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).
Mean Participant Survey Adherence Rate.
For each participant of the proportion of surveys measures completed (both daily and weekly surveys) will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Measured: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate.
For each participant of the proportion of EMA measures completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Measured: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Fitbit Device Adherence Rate.
For each participant, the proportion of days where the Fitbit device was worn will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Measured: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Participant Adherence to AYO Bright Blue Light Device.
For each participant, the proportion of days where 30-minute sessions using the bright blue light device were completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Measured: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Participant Adherence to AYO Dim Blue Light Device.
For each participant, the proportion of days where 30-minute sessions using the dim blue light device were completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Measured: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start20 Jan 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Karina Davidson, MASc, PhD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707846
- Sponsor's protocol ID
- 20-0835
- Other IDs
- R01LM012836
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2021
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Pooling N-of-1 trials together is a more efficient approach to deriving population-level estimates than conventional randomized controlled trials.
Publications
National Institutes of Health (2007). PROMIS domain framework definitions. http://www.nihpr omis.org/measu res/domai nframework .
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.
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.
PubMed 30296404Sasseville 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.
PubMed 26122037Meesters 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.
PubMed 29477098Smolders 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.
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.
PubMed 37721795Butler 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.
PubMed 36283748
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials of Light Therapy for Fatigue
- ClinicalTrials.gov ID
- NCT04707846
- Acronym / sponsor ID
- 20-0835
- Conditions
- Fatigue
- Keywords
- N-of-1, Fatigue, Virtual, Personalized Trial, Personalized, Feasibility, Light Therapy, Dim Light Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Columbia University, National Library of Medicine (NLM)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy | Experimental | Device: Bright Blue Light Commercial AYO Light Therapy DeviceIndividuals 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. |
| Dim Light Therapy | Active comparator | Device: Dim Blue Light Commercial AYO Light Therapy DeviceIndividuals 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). |
| 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). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Blue Light Commercial AYO Light Therapy DeviceAYO 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). | Device | Bright Light Therapy |
| Dim Blue Light Commercial AYO Light Therapy DeviceAYO 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). | Device | Dim Light Therapy |
Primary outcome
Mean System Usability Score (SUS).
Time frame: Assessed once after the results report has been sent to the participant, within 4 months of intervention completion.
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.
16 secondary outcomes
Within-Subject Difference in Self-reported Daily Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 7b Daily
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.
Time frame: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.
Time frame: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.
Time frame: 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).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.
Time frame: 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).
Within-Subject Difference in Fitbit Device-Recorded Daily Steps.
Time frame: 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).
Within-Subject Difference in Fitbit Device-Recorded Sleep Duration.
Time frame: 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).
Mean Participant Survey Adherence Rate.
Time frame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate.
Time frame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Fitbit Device Adherence Rate.
Time frame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Participant Adherence to AYO Bright Blue Light Device.
Time frame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Mean Participant Adherence to AYO Dim Blue Light Device.
Time frame: Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundNational Institutes of Health (2007). PROMIS domain framework definitions. http://www.nihpr omis.org/measu res/domai nframework .
- BackgroundBrooke, 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: PubMed 30296404Hanifin 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.
- Background: PubMed 26122037Sasseville 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.
- Background: PubMed 29477098Meesters 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.
- BackgroundSmolders 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.
- Derived from this study: PubMed 37721795Butler 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.
- Derived from this study: PubMed 36283748Butler 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.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Pooling N-of-1 trials together is a more efficient approach to deriving population-level estimates than conventional randomized controlled trials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina Davidson, MASc, PhD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Blue Light Commercial AYO Light Therapy Device and Dim Blue Light Commercial AYO Light Therapy Device in people with Fatigue, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean System Usability Score (SUS). (time frame: Assessed once after the results report has been sent to the participant, within 4 months of intervention completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04707846, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.