tDCS: Sleep to Mood in Depression (S2M-D)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
transcranial direct current stimulation (tDCS)
DeviceTranscranial 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Active transcranial direct current stimulation (tDCS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Post-Intervention (Week 5)Secondary outcomes
1
Change in wake after sleep onset (WASO)
WASO represents the sum of all wakefulness durations after sleep initiation.
Time frame
Baseline, Post-Intervention (Week 5)2
Change in night-to-night variability in sleep efficiency
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.
Time frame
Baseline, Post-Intervention (Week 5)3
Change in total sleep time
Time frame
Baseline, Post-Intervention (Week 5)4
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.
Time frame
Baseline, Post-Intervention (Week 5)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Zabara Foundation
Collaborator
Source ClinicalTrials.gov