NCT07658274

Brief Summary

The purpose of this study is to investigate the effects of transcutaneous electrical nerve stimulation (eTNS) applied during sleep on memory consolidation and brain-body physiological coupling. Healthy college students will participate in four overnight sleep sessions in a standard sleep laboratory. Before going to sleep, participants will learn and complete two cognitive tasks: a motor sequence tapping task to assess procedural memory, and an N-back task to assess working memory. During the night, participants will receive either 2 Hz eTNS, 120 Hz eTNS, or a sham (placebo) stimulation on their forehead in a randomized order. Throughout the night, researchers will record their sleep using polysomnography (PSG), along with continuous monitoring of heart rate (ECG) and breathing (respiration). Upon waking the next morning, participants will be re-tested on both memory tasks. The primary objective is to determine whether eTNS during sleep can improve behavioral performance on procedural and working memory tasks overnight. Secondary objectives include analyzing the stimulation's effects on specific sleep brain wave patterns (such as slow oscillations and sleep spindles) and exploring the coupling mechanisms between brain activity, heart rhythms (Heartbeat Evoked Potentials), and respiration during sleep.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

June 16, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 14, 2026

Last Update Submit

June 21, 2026

Conditions

Keywords

Transcutaneous Electrical Nerve StimulationeTNSProcedural MemoryWorking MemorySlow OscillationsSleep SpindlesHeartbeat Evoked PotentialsPolysomnography

Outcome Measures

Primary Outcomes (1)

  • Change in Procedural Memory Performance

    Procedural memory consolidation will be assessed using the classic sequential finger-tapping task (SFTT). Performance improvement is calculated as the difference in speed (number of correct sequences typed) and accuracy between the pre-sleep training/testing session and the post-sleep testing session. A larger positive difference indicates better procedural memory consolidation overnight.

    Assessed pre-sleep (approx. 21:00-22:00) and post-sleep (approx. 07:00-08:00 the following morning), representing an overnight interval of approximately 10 hours.

Secondary Outcomes (2)

  • Change in Working Memory Performance

    Assessed pre-sleep (approx. 21:00-22:00) and post-sleep (approx. 07:00-08:00 the following morning), representing an overnight interval of approximately 10 hours.

  • Sleep Architecture and Sleep Efficiency

    Continuously recorded during the 8-hour nighttime sleep period.

Other Outcomes (5)

  • Sleep Slow Oscillation (SO) Density and Amplitude

    Continuously recorded during the 8-hour nighttime sleep period (from lights out at 23:00 to waking up between 07:00 and 08:00).

  • Sleep Spindle Density and Amplitude

    Continuously recorded during the 8-hour nighttime sleep period.

  • Slow Oscillation-Spindle Coupling

    Continuously recorded during the 8-hour nighttime sleep period.

  • +2 more other outcomes

Study Arms (3)

120 Hz Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL
Device: 120 Hz Transcutaneous Electrical Nerve Stimulation

2 Hz Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL
Device: 2 Hz Transcutaneous Electrical Nerve Stimulation

Sham Stimulation (Placebo)

PLACEBO COMPARATOR
Device: Sham Stimulation (Placebo)

Interventions

Participants will receive 120 Hz transcutaneous electrical nerve stimulation (eTNS) during nighttime sleep. The stimulation is delivered via a current source stimulator connected to self-adhesive silicone electrodes placed above the left and right eyebrows. The stimulation consists of biphasic rectangular pulses with a 250 μs pulse width at a frequency of 120 Hz. It is delivered in continuous cycles of 30 seconds on and 30 seconds off. Before sleep, the current intensity is individually titrated to elicit a mild tingling sensation (corresponding to a score of 3-4 on a numerical rating scale) that will not disrupt the participant's sleep. The stimulation protocol automatically terminates after a duration of 8 hours.

120 Hz Transcutaneous Electrical Nerve Stimulation

Participants will receive 2 Hz transcutaneous electrical nerve stimulation (eTNS) during nighttime sleep. The stimulation is delivered via a current source stimulator connected to self-adhesive silicone electrodes placed above the left and right eyebrows. The stimulation consists of biphasic rectangular pulses with a 250 μs pulse width at a frequency of 2 Hz. It is delivered in continuous cycles of 30 seconds on and 30 seconds off. Before sleep, the current intensity is individually titrated to elicit a mild tingling sensation (corresponding to a score of 3-4 on a numerical rating scale) that will not disrupt the participant's sleep. The stimulation protocol automatically terminates after a duration of 8 hours.

2 Hz Transcutaneous Electrical Nerve Stimulation

Participants will receive a sham stimulation designed to serve as a placebo control. The equipment setup, including the placement of self-adhesive silicone electrodes above the left and right eyebrows, is identical to the active eTNS conditions. The current intensity is initially adjusted before sleep to elicit the same mild tingling sensation (a score of 3-4 on a numerical rating scale). However, to maintain double-blinding without providing a therapeutic dose, the stimulator only delivers current output during the first 2 minutes of the night (i.e., exactly two cycles of 30 seconds on and 30 seconds off). After these initial 2 minutes, the current output ceases entirely for the remainder of the 8-hour sleep period.

Sham Stimulation (Placebo)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults (e.g., college students), aged generally between 18 and 30 years.
  • Right-handed.
  • Body Mass Index (BMI) ≤ 30 kg/m\^2.
  • Capable of fully comprehending the experimental procedures and voluntarily signing the informed consent form.

You may not qualify if:

  • History or current presence of neurological disorders, psychiatric disorders, or brain damage.
  • History or current presence of cardiovascular diseases (e.g., arrhythmias or abnormal nocturnal heart rate).
  • Presence of depressive or anxiety symptoms (assessed by Patient Health Questionnaire-9 \[PHQ-9\] score \> 9, or Generalized Anxiety Disorder-7 \[GAD-7\] score \> 9).
  • Presence of sleep disturbances or poor sleep quality (assessed by Insomnia Severity Index \[ISI\] score \> 8, or Pittsburgh Sleep Quality Index \[PSQI\] score \> 10).
  • Any medication use within the past six months that could affect stress responses, cognitive abilities, or sleep architecture.
  • History of smoking or alcohol abuse.
  • Known skin allergies to conductive paste, medical tape, or silicone electrodes.
  • Female participants who are in their menstrual period during the scheduled experimental sessions (sessions must be strategically scheduled to avoid this period).
  • Inability or refusal to abstain from caffeine, tea, and alcohol for at least 24 hours prior to and during the experimental sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xidian University

Xi'an, Shaanxi, 71000, China

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 18, 2026

Study Start

June 16, 2026

Primary Completion

July 30, 2026

Study Completion

July 31, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations