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| Name | Class |
|---|---|
| Syntropic Medical | UNKNOWN |
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This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.
This pilot study will evaluate the tolerability, usability, and preliminary impact of a novel wearable device delivering 60Hz intermittent light for treatment of depressive symptoms in adults with MDD. All procedures are conducted remotely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Home-Based Intermittent Light Therapy | Experimental | Adults with a major depressive episode (MDE) randomized to receive active home-based 60Hz intermittent light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. |
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| Sham Home-Based Light Therapy | Sham Comparator | Adults with a major depressive episode (MDE) randomized to receive sham home-based light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60Hz Intermittent Light Therapy | Device | Intermittent 60 Hz flickering white light delivered via a wearable headset. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants who Complete all Scheduled Sessions | Measure of retention; 15 sessions scheduled in total. | Up to Week 3 |
| Average Percentage of Completed Sessions | Measure of adherence; 15 sessions scheduled in total. | Up to Week 3 |
| Proportion of Participants who Discontinue due to Adverse Effects | Measure of tolerability. | Up to Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Ã…sberg Depression Rating Scale (MADRS) Score | The MADRS is a 10-item assessment of depression; each item is rated on a 7-point scale from 0 to 6. The total score is the sum of responses and ranges from 0 to 60; higher scores indicate greater severity of depression. | Baseline, Week 3 |
| Change in Hamilton Depression Rating Scale (HDRS-17) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shayna Pehel | Contact | 929-455-5104 | Shayna.Pehel@nyulangone.org | |
| Giuseppina Pilloni | Contact | 929-455-5317 | Giuseppina.Pilloni@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppina Pilloni, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10017 | United States |
Individual participant data (IPD) will not be shared due to the small sample size and risk of re-identification, as well as the exploratory nature of the pilot study.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| Sham Light Therapy | Device | Constant white light delivered via a wearable headset. |
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The HDRS-17 is a 17-item scale assessing the severity of depression. Most items are rated on a 5-point scale (0-4), with some using a 3-point scale (0-2). The total score is the sum of responses and ranges from 0-52; higher scores indicate greater severity of depression. |
| Baseline, Week 3 |
| Change in Patient Health Questionnaire (PHQ-9) Score | The PHQ-9 is a 9-item scale assessing the prevalence of depressive symptoms. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-27; higher scores indicate greater prevalence of depressive symptoms. | Baseline, Week 3 |
| Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score | The QIDS-SR is a 15-item scale assessing depressive symptoms over the previous 7 days. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-45; higher scores indicate greater prevalence of depressive symptoms. | Baseline, Week 3 |
| Change in Work and Social Adjustment Scale (WSAS) Score | The WSAS is a 5-item scale assessing the impact of mental health on daily activities. Each item is rated on a 9-point Likert scale from 0 to 8. The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe impairment on daily activities. | Baseline, Week 3 |
| Change in Generalized Anxiety Disorder (GAD-7) Score | The GAD-7 is a 7-item scale assessing the severity of generalized anxiety disorder. Each item is rated on a scale from 0 to 3. The total score is the sum of responses and ranges from 0-21 with higher scores indicating more severe anxiety. | Baseline, Week 3 |
| Post-Study System Usability Questionnaire (PSSUQ) Score | The PSSUQ assesses the overall usability of the intervention; each of the 16 items is rated on a scale from 1-7. The total score is the sum of responses and ranges from 16 to 112; higher scores indicate greater usability of the intervention. | Week 3 |
| System Usability Scale (SUS) Score | The SUS is a 10-item assessment of the usability of the intervention; the items are rated on a scale from 1-5. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater usability of the intervention. | Week 3 |
| Net Promoter Score (NPS) | The NPS is a single-item questionnaire asking participants how likely they are to recommend the intervention to a colleague. The total score ranges from 1-10; higher scores indicate greater likelihood of promoting the intervention. | Week 3 |
| Brief Blinding Questionnaire (BBQ) Score | After completing the intervention phase of the study, effectiveness of participant blinding will be assessed using a 3-item questionnaire. The outcome will be scored as the percentage of participants who correctly guess their blinding assignment. | Week 3 |
| Adverse Events | Incidence of spontaneously reported adverse events during the intervention period. Incidence and type will be reported in the "Adverse Events" section of the results. | Week 3 |
| D001523 |
| Mental Disorders |