Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Обзор

Study Purpose The purpose of this clinical trial is to investigate whether low-intensity frontal vibration can improve sleep performance in individuals with chronic insomnia. Additionally, the study aims to explore its potential effects on memory enhancement. The primary objectives of the study are to address the following questions: * Does low-intensity frontal vibration improve sleep performance in patients with chronic insomnia? * Does low-intensity frontal vibration enhance memory performance in patients with chronic insomnia? Researchers will compare the effects of low-intensity frontal vibration with a sham stimulation (in which participants hear only noise associated with the vibration process) to determine whether the active intervention can effectively improve symptoms of chronic insomnia. Participant Involvement Participants in the study will: * Record daily sleep diaries via a mobile application for a total of 9 weeks * Receive daily intervention during a 4-week intervention phase as scheduled by the study * Complete weekly self-reported sleep questionnaires through the app * Undergo memory performance assessments at the beginning and end of the study

Вмешательства

• Устройство Vibrational stimulation
  Fifteen minutes before bedtime, participants will wear a vibration stimulation device on the forehead while lying down in a comfortable position. The stimulation intensity will be set to 60% of the device's maximum output. Participants will receive a 15-minute session of 40 Hz vibration stimulation with a 50% duty cycle: 15 seconds of stimulation followed by 15 seconds of rest, repeated continuously. After the session, participants will remove the device and prepare for sleep immediately.
• Другое Sham
  Fifteen minutes before bedtime, participants will lie down in a comfortable position and listen to the 40 Hz noise generated by the vibration device (without receiving actual vibration). After the session, they will remove the device and prepare for sleep immediately.

Первичные конечные точки

• Pittsburgh Sleep Quality Index Scale(PSQI) [Срок оценки: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)]

Вторичные конечные точки (7)

• The Insomnia Severity Index Scale(ISI) [Срок оценки: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each weekduring 4-week follow-up)]
• Epworth Sleepiness Scale(ESS) [Срок оценки: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)]
• Patient Health Questionnaire (PHQ-9) [Срок оценки: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)]
• Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)]
• Sleep Diary [Срок оценки: Daily recording for the duration of the 63-day trial.]
• Memory Task [Срок оценки: baseline(Day 1); intervention stage(The last day of 4-week intervention, an average of Day 35); follow-up stage(The last day 4-week stage, an average of Day 63)]
• Intervention Experience [Срок оценки: through study completion, an average of 63 days]

Критерии участия

Критерии включения

• Aged 18 to 65 years, regardless of gender;
• Diagnosed with chronic insomnia disorder according to DSM-5 criteria, with a primary complaint of difficulty falling asleep (sleep onset latency > 30 minutes), occurring ≥3 times per week, lasting for more than 3 months but less than 3 years;
• Able to independently operate a smartphone, and capable of completing self-reported assessments and applying the self-administered intervention after instruction.

Критерии исключения

• Presence of sleep disorders such as sleep apnea syndrome or restless legs syndrome;
• Epworth Sleepiness Scale (ESS) score > 10;
• Use of any sleep-related medication within the past month;
• Patient Health Questionnaire-9 (PHQ-9) score > 15 or Generalized Anxiety Disorder-7 (GAD-7) score > 10;
• Currently participating in any form of cognitive behavioral therapy or neuromodulation intervention study;
• Working night shifts or rotating shifts;
• Clinically diagnosed neurological disorders such as epilepsy, stroke, dementia, or Parkinson's disease, or psychiatric disorders such as bipolar disorder, obsessive-compulsive disorder, phobias, or panic disorder;
• Substance abuse (including alcohol or drugs), defined as more than 14 drinks/week for males or 12 drinks/week for females.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University — Шанхай

Идентификаторы

NCT: NCT06983275 · Vibrational sleep intervention

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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