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Healthy Volunteers (HV)NCT07658274

Electrical Nerve Stimulation During Sleep for Memory Consolidation

A study testing 120 Hz Transcutaneous Electrical Nerve Stimulation and 2 Hz Transcutaneous Electrical Nerve Stimulation in people with Healthy Volunteers (HV), run by Xidian University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers (HV)
What is being tested?
120 Hz Transcutaneous Electrical Nerve Stimulation and 2 Hz Transcutaneous Electrical Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
16 Jun 2026to 31 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xue-Juan Yang contact

13227038185

xjyang@xidian.edu.cn

China1 site, 1 recruiting
  • Xidian University

    Xi'an, Shaanxi, 71000

    Xue-Juan Yang, 13227038185, xjyang@xidian.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Effects of 2 Hz and 120 Hz Transcutaneous Electrical Nerve Stimulation During Sleep on Procedural Memory and Working Memory: A Randomized, Sham-Controlled, Crossover Study

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.

Read the detailed description

This study utilizes a randomized, double-blind, sham-controlled, within-subject crossover design to evaluate the modulatory effects of transcutaneous electrical nerve stimulation (eTNS) during sleep on memory consolidation and cardiopulmonary-brain coupling.

Healthy young adults will be recruited and rigorously screened to exclude those with sleep disorders, neurological or psychiatric conditions, or recent use of medications affecting sleep or cognition. Each participant will complete four overnight sessions in a standard soundproof and lightproof sleep laboratory, separated by 5-7 days. The first night serves as an adaptation night with no stimulation or data collection. The subsequent three nights involve experimental recordings under varying stimulation conditions (2 Hz eTNS, 120 Hz eTNS, and sham stimulation) applied in a randomized order.

Experimental Procedure:

On experimental nights, participants will arrive at the laboratory at 21:00. Prior to sleep, participants will undergo a training and baseline testing phase for two distinct cognitive tasks: a procedural memory task (the classic sequential finger-tapping task) and a working memory task (the 2- to 5-back task). Following the pre-sleep tasks, participants will be fitted with polysomnography (PSG) equipment, electrocardiogram (ECG) sensors, and respiratory monitors. Lights-out is scheduled for 23:00. Upon awakening between 07:00 and 08:00 the following morning, participants will be re-tested on both the sequential finger-tapping task and the N-back task to assess overnight memory consolidation.

Stimulation Parameters:

During sleep, eTNS will be delivered via a three-channel 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. For the active conditions (120 Hz or 2 Hz), the current is delivered in cycles of 30 seconds on and 30 seconds off. The current intensity will be titrated to a subjective score of 3-4 on a numerical rating scale (NRS), perceived as a mild tingling sensation that does not disrupt sleep. The sham condition delivers current only for the first two minutes (the first two cycles) to mimic the initial sensation of the active conditions. All stimulations automatically terminate after a maximum duration of 8 hours.

Data Collection and Analysis Framework:

Continuous PSG recording (including standard EEG, EOG, and EMG based on the international 10-20 system) will be synchronized with simultaneous ECG and respiration data. The study will primarily compare the pre- and post-sleep behavioral improvements across the three stimulation conditions. Furthermore, the neurophysiological data will be analyzed to extract sleep structural features, slow oscillation (SO) and sleep spindle metrics, and complex physiological interactions. Specific focus will be placed on SO-spindle coupling, SO-respiration coupling, and Heartbeat Evoked Potentials (HEP) to elucidate the underlying neural and autonomic mechanisms by which peripheral stimulation influences cognitive functions during sleep.

Being tested
120 Hz Transcutaneous Electrical Nerve Stimulation, 2 Hz Transcutaneous Electrical Nerve Stimulation, Sham Stimulation (Placebo)
Keywords
Transcutaneous Electrical Nerve Stimulation, eTNS, Procedural Memory, Working Memory, Slow Oscillations, Sleep Spindles, Heartbeat Evoked Potentials, Polysomnography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 120 Hz Transcutaneous Electrical Nerve StimulationDevice

    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.

  • 2 Hz Transcutaneous Electrical Nerve StimulationDevice

    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.

  • Sham Stimulation (Placebo)Device

    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.

Study groups in NCT07658274
Study groupRoleWhat they receive
120 Hz Transcutaneous Electrical Nerve StimulationExperimentalNot described
Receives: Device: 120 Hz Transcutaneous Electrical Nerve Stimulation
2 Hz Transcutaneous Electrical Nerve StimulationExperimentalNot described
Receives: Device: 2 Hz Transcutaneous Electrical Nerve Stimulation
Sham Stimulation (Placebo)Placebo comparatorNot described
Receives: Device: Sham Stimulation (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Change in Working Memory Performance

    Working memory performance will be assessed using the 2- to 5-back task. Outcome metrics include reaction time and accuracy (hit rate and false alarm rate). The overnight change is calculated by comparing the performance in the post-sleep testing session to the pre-sleep baseline session. Higher accuracy and shorter reaction times indicate improved working memory function.

    Measured: 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.

  2. Sleep Architecture and Sleep Efficiency

    Sleep architecture will be derived from PSG scoring according to the American Academy of Sleep Medicine (AASM) criteria. Key metrics include Total Sleep Time (TST), Sleep Efficiency (SE, calculated as TST divided by Time in Bed), and the percentage of time spent in different sleep stages (N1, N2, N3, and REM sleep). This ensures the stimulation does not negatively disrupt normal sleep patterns.

    Measured: Continuously recorded during the 8-hour nighttime sleep period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study start16 Jun 2026 (estimated)
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07658274
Sponsor's protocol ID
20260615
Status last verified
Jun 2026
First submitted
14 Jun 2026
Last updated
24 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 120 Hz Transcutaneous Electrical Nerve Stimulation and 2 Hz Transcutaneous Electrical Nerve Stimulation in people with Healthy Volunteers (HV), run by Xidian University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xue-Juan Yang (13227038185, xjyang@xidian.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Procedural Memory Performance (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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