Hematopoietic Stem Cell TransplantNCT06496477
Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
A study testing Ayo wearable in people with Hematopoietic Stem Cell Transplant, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The participants are being asked to be in this clinical trial, a type of research study, because the participants are going to have a hematopoietic stem cell transplant (HSCT) in the near future. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- Ayo wearable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥8 to <18 years of age at the time of enrollment
- Allogeneic HSCT planned to occur between 7 and 10 days in the future from recruitment
- Patient and/or primary caregiver reads and writes in English or Spanish
- Participant/guardian is willing to sign informed consent
- Optional interview participants must be English speaking
- Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) ≥ 55
Who cannot join
- Taking photosensitizing medications
- Total blindness / complete lack of light perception bilaterally
- Significant physiological or psychological impairment that interferes with participation
- Any patient that, in the opinion of the primary investigator is not appropriate for the study
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Non-English-speaking participants will not be eligible for the optional qualitative interview
- Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) < 55
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
The participants are being asked to be in this clinical trial, a type of research study, because the participants are going to have a hematopoietic stem cell transplant (HSCT) in the near future. Participants that get HSCT's often get depression and/or suffer from depressive symptoms, tiredness, and sleep disturbances.
Primary Objective
Read more
To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant.
Secondary Objectives
- To evaluate the temporal effect and magnitude of BL vs. DL therapy on depression in pediatric patients undergoing HSCT.
- To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant.
- To evaluate the response of BL therapy versus DL on sleep quality.
Exploratory Objectives
- To compare incidence of positive delirium screenings between those receiving BL therapy versus DL
- To evaluate participant and caregiver perceptions of the acceptability, ease of use, and risks/benefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews.
Read the detailed description
If you decide to be in this study, you will be asked to:
- Complete some surveys before the study begins
- Take more surveys for about 4 weeks
- Wear light therapy glasses for about 30 minutes each day for about 4 weeks
- Wear a wrist monitor every day and night for the 1st and last week of the study to record your motion and sleeping habits.
- Keep a ''sleep diary" where you will mark the times that you sleep while wearing the wrist monitor.
- Complete an optional interview at the end of the study.
- Conditions
- Hematopoietic Stem Cell Transplant
- Being tested
- Ayo wearable
- Keywords
- Depression, Sleep, Fatigue
- Medical subject headings
- Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayo wearableDevice
Primary study device - the Ayo wearable which are glasses that emit either bright blue-spectrum white light or dim blue-spectrum white light or Mini motion logger AAM-32 - an actigraphy device work during the first and last week of the study on the participants wrist throughout most of the day, measuring activity. This will be used as an indicator of sleep.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-A bright blue-spectrum white light (BL | Active comparator | Participants will receive therapy with bright blue-spectrum white light (BL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission Receives: Device: Ayo wearable |
| Group 2- A dim blue-spectrum white light control (DL | Active comparator | Participants will receive therapy with dim blue-spectrum white light control (DL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission Receives: Device: Ayo wearable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Efficacy
Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these scores and receive weekly re-evaluation through the approximately 4-week study period.
Measured: Baseline
Secondary outcomes (3)
Magnitude and Temporality of Effect in Depression
Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these scores and receive weekly re-evaluation through the approximately 4-week study period. Sequential assessments are to determine the magnitude of response and time to effect of the intervention between the treatment and control conditions.
Measured: Baseline
Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective)
PROMIS Ped CAT v2.0 - Fatigue (Patient and Parent Proxy)
Measured: Baseline
Impact on Sleep Quality"
Participants will wear actigraphy devices (the Mini Motion Logger AAM-32) for at least 3 days from day 0 - day 7 ± 3 days post-transplant (baseline sleep measures) and at least 3 days from day 21 - 28 ± 3 days post-transplant. Actigraphy devices will be distributed at day 0 and 21 ± 3 days post-transplant and collected on day 7 and 28 ± 3 days post-transplant by a research team member while completing regularly planned study visits. During the days the device is worn, participants will do so for as much time during each day as possible, with near continuous wear being recommended. The device will collect data regarding the participants sleep minutes, sleep efficiency, defined as the percentage of time in bed spent sleeping, and wake after sleep onset, defined as minutes of awakening during a sleep phase. Data will be compared between participants receiving BL versus DL interventions in our study cohort.
Measured: Actigraphy devices will be worn for at least 3 days from day 0 - day 7 ± 3 days post-transplant and at least 3 days from day 21 - 28 ± 3 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study startApr 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Why it stopped: The study did not enroll participants and had not shown significant progress since the initial IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Elliott, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496477
- Sponsor's protocol ID
- SJLIGHT
- Other IDs
- NCI-2025-03591
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
- ClinicalTrials.gov ID
- NCT06496477
- Acronym / sponsor ID
- SJLIGHT
- Conditions
- Hematopoietic Stem Cell Transplant
- Keywords
- Depression, Sleep, Fatigue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not enroll participants and had not shown significant progress since the initial IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The participants are being asked to be in this clinical trial, a type of research study, because the participants are going to have a hematopoietic stem cell transplant (HSCT) in the near future. Participants that get HSCT's often get depression and/or suffer from depressive symptoms, tiredness, and sleep disturbances.
Primary Objective
To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant.
Secondary Objectives
- To evaluate the temporal effect and magnitude of BL vs. DL therapy on depression in pediatric patients undergoing HSCT.
- To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant.
- To evaluate the response of BL therapy versus DL on sleep quality.
Exploratory Objectives
- To compare incidence of positive delirium screenings between those receiving BL therapy versus DL
- To evaluate participant and caregiver perceptions of the acceptability, ease of use, and risks/benefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews.
Detailed description
If you decide to be in this study, you will be asked to:
- Complete some surveys before the study begins
- Take more surveys for about 4 weeks
- Wear light therapy glasses for about 30 minutes each day for about 4 weeks
- Wear a wrist monitor every day and night for the 1st and last week of the study to record your motion and sleeping habits.
- Keep a ''sleep diary" where you will mark the times that you sleep while wearing the wrist monitor.
- Complete an optional interview at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-A bright blue-spectrum white light (BL | Active comparator | Device: Ayo wearableParticipants will receive therapy with bright blue-spectrum white light (BL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission |
| Group 2- A dim blue-spectrum white light control (DL | Active comparator | Device: Ayo wearableParticipants will receive therapy with dim blue-spectrum white light control (DL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age ≥8 to <18 years of age at the time of enrollment
- Allogeneic HSCT planned to occur between 7 and 10 days in the future from recruitment
- Patient and/or primary caregiver reads and writes in English or Spanish
- Participant/guardian is willing to sign informed consent
- Optional interview participants must be English speaking
Key exclusion criteria (7 listed)
- Taking photosensitizing medications
- Total blindness / complete lack of light perception bilaterally
- Significant physiological or psychological impairment that interferes with participation
- Any patient that, in the opinion of the primary investigator is not appropriate for the study
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
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 |
|---|---|---|
| Ayo wearablePrimary study device - the Ayo wearable which are glasses that emit either bright blue-spectrum white light or dim blue-spectrum white light or Mini motion logger AAM-32 - an actigraphy device work during the first and last week of the study on the participants wrist throughout most of the day, measuring activity. This will be used as an indicator of sleep. | Device | Group 1-A bright blue-spectrum white light (BL, Group 2- A dim blue-spectrum white light control (DL |
Primary outcome
Depression Efficacy
Time frame: Baseline
Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these scores and receive weekly re-evaluation through the approximately 4-week study period.
3 secondary outcomes
Magnitude and Temporality of Effect in Depression
Time frame: Baseline
Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective)
Time frame: Baseline
Impact on Sleep Quality"
Time frame: Actigraphy devices will be worn for at least 3 days from day 0 - day 7 ± 3 days post-transplant and at least 3 days from day 21 - 28 ± 3 days post-transplant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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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.
Andrew Elliott, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayo wearable in people with Hematopoietic Stem Cell Transplant, run by St. Jude Children's Research Hospital 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 Jun 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Depression Efficacy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.