Efficacy, Safety, and Feasibility of a Home-Based Auricular Transcutaneous Electrical Stimulation Intervention Using a Low-Frequency TENS-Like Device to Improve Sleep Quality and Psycho-Academic Outcomes in Health Sciences Students: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
研究概览
简要总结
This study aims to evaluate the efficacy, safety, and feasibility of a home-based auricular transcutaneous vagus nerve stimulation (tVNS) program in Health Sciences university students with poor sleep quality. Participants will be randomly assigned (1:1) to receive either active auricular stimulation (cymba conchae/tragus) or a control stimulation applied to the earlobe. The intervention will be self-administered at home using a low-frequency TENS-like device for 60 minutes per session, 5 sessions per week for 3 weeks. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention. Secondary outcomes include insomnia severity, daytime sleepiness, perceived stress, anxiety, quality of life, and psycho-academic outcomes.
详细描述
Sleep disturbances are highly prevalent among university students and are frequently associated with academic stress and impaired psycho-academic functioning. Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation approach with potential to modulate autonomic function and stress responses, which may contribute to improvements in sleep quality.
This study is designed as a randomized controlled pilot trial to assess the efficacy, safety, and feasibility of a home-based auricular tVNS intervention in Health Sciences university students. Eligible participants will be aged 18-35 years and will present poor sleep quality (PSQI > 7) and primary insomnia criteria. Participants will be recruited from two academic centers (University of Malaga and Centro Universitario San Isidoro, affiliated with Pablo de Olavide University, Seville) and will be randomly allocated (1:1) to one of two arms: (1) active auricular stimulation targeting the left cymba conchae (with tragus as an alternative if needed), or (2) control (sham) stimulation delivered to the ipsilateral earlobe. Randomization will be performed using block randomization, and outcome assessors and data analysts will remain blinded to group assignment.
The intervention will be delivered at home using a low-frequency TENS-like device with biphasic symmetrical waveform (25 Hz, 200 μs pulse width), administered for 60 minutes per session, 5 sessions per week for 3 weeks. Stimulation intensity will be individually adjusted to achieve a clear but comfortable paresthetic sensation below the pain threshold. Adherence will be monitored using an electronic diary with time stamps and daily photographic verification of electrode placement.
The primary outcome is sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) pre- and post-intervention. Secondary outcomes include insomnia severity (ISI), daytime sleepiness (ESS), perceived stress (PSS-14), anxiety measures (e.g., BAI and HAMA), depressive symptoms (HAMD), fatigue (FFS), and health-related quality of life (SF-12 v2). Psycho-academic outcomes will be measured using self-reported GPA and credits passed at the end of the semester. Safety will be assessed through systematic recording of adverse events throughout the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are blinded to group allocation. Outcome assessors and data analysts are blinded to treatment assignment. The control condition consists of stimulation applied to the earlobe to mimic sensory stimulation without active auricular vagal stimulation.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 35 years.
- •Undergraduate student enrolled in a Health Sciences degree program.
- •Poor sleep quality defined as PSQI >
- •Meets diagnostic criteria for primary insomnia according to ICSD-
- •Ability to understand study procedures and provide written informed consent.
- •Willing and able to self-administer the intervention at home and complete study questionnaires.
排除标准
- •Current severe psychiatric disorder or ongoing psychotherapy treatment.
- •Neurological disorders (e.g., epilepsy).
- •Cardiac arrhythmias or implanted cardiac devices (e.g., pacemaker).
- •Current use of medications that significantly affect sleep (e.g., hypnotics or anxiolytics), unless stable and approved by the investigator.
- •Pregnancy.
- •Ear infection, skin lesions, or dermatologic condition preventing electrode placement.
- •Hypersensitivity or intolerance to electrical stimulation.
- •Participation in another clinical trial within the last 30 days.
研究组 & 干预措施
Active tVNS
Home-based auricular transcutaneous vagus nerve stimulation (tVNS) applied to the left cymba conchae (or tragus if needed) using a low-frequency TENS-like device. Sessions are performed for 60 minutes, 5 days/week for 3 weeks. Stimulation intensity is adjusted to a strong but comfortable paresthesia below pain threshold.
干预措施: Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) (Device)
Control (Earlobe Stimulation)
Control stimulation delivered to the ipsilateral earlobe using the same device and schedule as the active intervention (60 minutes, 5 days/week for 3 weeks) to mimic sensory stimulation without targeting auricular vagal afferents.
干预措施: Sham stimulation (Device)
结局指标
主要结局
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
时间窗: Baseline and end of week 3
PSQI total score (0-21). Higher scores indicate worse sleep quality.
Anxiety Symptoms (Beck Anxiety Inventory, BAI)
时间窗: Baseline and end of week 3
BAI total score. Higher scores indicate greater anxiety symptoms.
次要结局
- Insomnia Severity (Insomnia Severity Index, ISI)(Baseline and end of week 3)
- Daytime Sleepiness (Epworth Sleepiness Scale, ESS)(Baseline and end of week 3)
- Perceived Stress (Perceived Stress Scale-14, PSS-14)(Baseline and end of week 3)
- Quality of Life (12-Item Short Form Survey, SF-12 v2)(Baseline and end of week 3)
- Academic Performance (GPA and Credits Passed)(Baseline and end of semester (up to 16 weeks))
研究者
Ismael Romero García
Principal Investigator / PhD Candidate
University of Malaga