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| Name | Class |
|---|---|
| Zabara Foundation | UNKNOWN |
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The purpose of this study is to determine whether changes in sleep consolidation occur during home-based transcranial direct current stimulation (tDCS) in adults with moderate depression and whether these changes are temporally associated with improvements in depressive symptoms.
This study evaluates the effects of home-based transcranial direct current stimulation (tDCS) on sleep and depressive symptoms in adults with moderate depression. tDCS is a noninvasive neuromodulation technique that delivers a mild electrical current to the scalp to modulate brain activity and has been studied as a potential treatment for depression.
Participants will self-administer tDCS for 20 sessions at home over the course of the study. Sleep will be continuously monitored using a wearable device called an Oura Ring that captures sleep measures such as sleep duration, efficiency, awakenings, and night-to-night consistency. Depressive symptoms will be assessed longitudinally using validated clinical and self-report measures.
The primary objective is to determine whether changes in sleep consolidation occur over the course of tDCS treatment. A secondary objective is to evaluate whether changes in sleep are temporally associated with improvements in depressive symptoms.
This study aims to better characterize the relationship between sleep and depressive response during tDCS, and to identify potential sleep-related markers associated with clinical improvement in depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active transcranial direct current stimulation (tDCS) | Experimental | Participants will complete a 20-session course of home-based left dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) (2.0 mA, 30 minutes per session). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (tDCS) | Device | Transcranial direct current stimulation delivers a gentle, low-intensity electrical current. The tDCS device is programmed to ramp up to 2.0 mA (for 30 seconds), deliver constant current throughout the session (29 minutes), and then ramp down (for 30 seconds) at the end of the session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep efficiency | Sleep efficiency (SE) is the percentage of time spent asleep while in bed. A healthy, normal efficiency is 85% or higher, with 90% or more considered very good. Low efficiency can indicate poor sleep quality. | Baseline, Post-Intervention (Week 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wake after sleep onset (WASO) | WASO represents the sum of all wakefulness durations after sleep initiation. | Baseline, Post-Intervention (Week 5) |
| Change in night-to-night variability in sleep efficiency |
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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 | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | 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 study.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Night-to-night variability in sleep efficiency is measured as the percentage of time in bed actually spent sleeping. High variability can indicate poor sleep quality.
| Baseline, Post-Intervention (Week 5) |
| Change in total sleep time | Baseline, Post-Intervention (Week 5) |
| Change in sleep latency | Sleep latency is the time it takes to transition from full wakefulness to sleep. An ideal sleep latency is typically 10-20 minutes. | Baseline, Post-Intervention (Week 5) |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS-S) score | MADRS-s is a 10-item self report questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression. | Baseline, Final Follow-Up Study Visit (Month 2) |
| Change in Patient Health Questionnaire-8 (PHQ-8) score | The PHQ-8 consist of 8-items. Participants self-report the severity of current depression. Each item is scored 0-3 based on frequency (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day), with a total score ranging from 0 to 24. Higher scores indicate severe depression. | Baseline, Final Follow-Up Study Visit (Month 2) |
| Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) score | The QIDS-SR is a 16-item self-report tool used to measure the severity of depressive symptoms. Scores range from 0-27, with higher scores indicating clinically significant depression. | Baseline, Final Follow-Up Study Visit (Month 2) |
| D001519 |
| Behavior |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |