Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
ConditionChronic Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJia Xiu
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Vibrational stimulation
DeviceFifteen 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.
Sham
Other interventionFifteen 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Control groupPlacebo comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pittsburgh Sleep Quality Index Scale(PSQI)
A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome
Time frame
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)Secondary outcomes
1
The Insomnia Severity Index Scale(ISI)
A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome
Time frame
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)2
Epworth Sleepiness Scale(ESS)
A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome
Time frame
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)3
Patient Health Questionnaire (PHQ-9)
A scale that evaluates the severity of depression, the scale scores range from 0 to 27, and lower scores mean a better outcome
Time frame
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)4
Generalized Anxiety Disorder-7 (GAD-7)
A scale that evaluates anxiety, the scale scores range from 0 to 21, and lower scores mean a better outcome
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jia Xiu
Lead sponsor
Fudan University
Sponsor institution
Shanghai Minhang Central Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
The Affiliated Brain Hospital of Nanjing Medical University
Collaborator
Source ClinicalTrials.gov