tDCS: Sleep to Mood in Depression (S2M-D)
2026년 6월 5일 업데이트: NYU Langone Health
Sleep Consolidation as a Mechanistic Pathway Linking Home-Based tDCS to Antidepressant Response (S2M-D)
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
35
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Shayna Pehel
- 전화번호: 929-455-5104
- 이메일: Shayna.Pehel@nyulangone.org
연구 연락처 백업
- 이름: Giuseppina Pilloni
- 전화번호: 929-455-5317
- 이메일: Giuseppina.Pilloni@nyulangone.org
연구 장소
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New York
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New York, New York, 미국, 10016
- 모병
- NYU Langone Health
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Ability to read and understand study materials in English, as demonstrated by a standard score >85 on the WRAT-5 Reading Recognition Subtest
- MADRS-S ≥18 during screening
- Confirmed diagnosis of MDD, based on clinician interview
- If taking antidepressant medication, the dose must be stable for at least 30 days prior to pre-screening.
- Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms OR confirmed acknowledgement and identification of local resources.
- Able to provide informed consent and comply with study procedures.
- Access to a quiet space suitable for home-based tDCS stimulation sessions.
Exclusion Criteria:
- Current major medical condition that, in the opinion of the study clinician, would interfere with study participation, safety, or interpretation of study outcomes.
- Current or past bipolar disorder, psychotic disorder, or current (past 6 months) alcohol or substance use disorder, as determined by clinician assessment at screening.
- Clinically significant suicidal ideation or behavior, based on clinician assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Use of prescription or over-the-counter sleep-promoting medications or initiation of behavioral interventions specifically targeting sleep in the past 30 days from pre-screening.
- History of seizure disorder or epilepsy.
- Presence of an active implanted medical device above the neck (e.g., deep brain stimulator, cochlear implant) or non-MRI-compatible metallic implants in the head or neck region.
- Current use of prescription or over-the-counter sleep medications, or active participation in any behavioral or pharmacologic treatment specifically targeting sleep.
- Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding o If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Active transcranial direct current stimulation (tDCS)
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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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in sleep efficiency
기간: Baseline, Post-Intervention (Week 5)
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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.
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Baseline, Post-Intervention (Week 5)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in wake after sleep onset (WASO)
기간: Baseline, Post-Intervention (Week 5)
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WASO represents the sum of all wakefulness durations after sleep initiation.
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Baseline, Post-Intervention (Week 5)
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Change in night-to-night variability in sleep efficiency
기간: Baseline, Post-Intervention (Week 5)
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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.
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Baseline, Post-Intervention (Week 5)
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Change in total sleep time
기간: Baseline, Post-Intervention (Week 5)
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Baseline, Post-Intervention (Week 5)
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Change in sleep latency
기간: Baseline, Post-Intervention (Week 5)
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Sleep latency is the time it takes to transition from full wakefulness to sleep.
An ideal sleep latency is typically 10-20 minutes.
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Baseline, Post-Intervention (Week 5)
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Change in Montgomery-Åsberg Depression Rating Scale (MADRS-S) score
기간: Baseline, Final Follow-Up Study Visit (Month 2)
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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.
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Baseline, Final Follow-Up Study Visit (Month 2)
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Change in Patient Health Questionnaire-8 (PHQ-8) score
기간: Baseline, Final Follow-Up Study Visit (Month 2)
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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.
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Baseline, Final Follow-Up Study Visit (Month 2)
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Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) score
기간: Baseline, Final Follow-Up Study Visit (Month 2)
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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.
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Baseline, Final Follow-Up Study Visit (Month 2)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 4일
기본 완료 (추정된)
2027년 11월 30일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 5월 1일
QC 기준을 충족하는 최초 제출
2026년 5월 1일
처음 게시됨 (실제)
2026년 5월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 5일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26-00329
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .