tDCS: Sleep to Mood in Depression (S2M-D)
2026年6月5日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
35
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Shayna Pehel
- 電話番号：929-455-5104
- メール：Shayna.Pehel@nyulangone.org
研究連絡先のバックアップ
- 名前：Giuseppina Pilloni
- 電話番号：929-455-5317
- メール：Giuseppina.Pilloni@nyulangone.org
研究場所
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New York
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New York、New York、アメリカ、10016
- 募集
- NYU Langone Health
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in sleep efficiency
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in wake after sleep onset (WASO)
時間枠：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
時間枠：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
時間枠：Baseline, Post-Intervention (Week 5)
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Baseline, Post-Intervention (Week 5)
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Change in sleep latency
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月4日
一次修了 (推定)
2027年11月30日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年5月1日
QC基準を満たした最初の提出物
2026年5月1日
最初の投稿 (実際)
2026年5月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月5日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 26-00329
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
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