Transcranial focused ultrasound stimulation for sleep control
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0007512
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
a. Adult men and women aged between 20 and under 65
(Based on selection: Including young people, middle-aged, and adults in early old age, excluding children, adolescents, and the elderly who can participate in clinical trials according to their voluntarily and faithfully participation in research.)
b. Subjects who consented to participate in this study and signed a written informed consent
c. Those who have completed the Pittsburgh Sleep Quality Index (PSQI) test
?: According to previous studies, PSQI score of 5 or less on a 5-point scale was evaluated as sufficient sleep, and a score of 6 or higher was evaluated as poor quality of sleep.
a. Subjects with a history of being diagnosed with a neuropsychiatric disorder, or with the diagnosis of following sleep disorders or symptoms
- Moderate to severe symptomatic snoring, and/or Sleep apnea with more than an apnea-hypopnea index of 15/hour
- History of Narcolepsy or Periodic limb movement during sleep
- Comorbid psychiatric diseases such as major depressive disorder
b. If you have experienced undue stressful changes within 2 weeks of your first visit:
Spouse death, family discord, lawsuit/dispute, sudden hardship, etc.
c. Those taking medications that could significantly affect sleep maintenance and onset within 1 month of the first visit
d. Among those taking drugs or food that may affect sleep, those who find it difficult to maintain or stop taking drugs or food according to the guidance of the medical staff from 2 weeks before the start of the test until the end of the test
e. People who consume excessive alcohol on a regular basis (>140g/week, about 2.5 bottles/week of soju, about 2.5 glasses/day)
f. People who smoke excessively (> 10 cigarettes/day)
g. People who consume excessive caffeine on a regular basis (> 10 cups of coffee per day)
h. Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more
i. Those who participated in the clinical trial within 1 month of the first visit
j. Pregnant women (positive hCG pregnancy test in urine) or women planning to become pregnant
k. Those who cannot receive brain CT and MRI examinations
l. Those who have a skull thickness of 8 mm or more or have clinically significant calcification in brain CT examination
m. Those with structural abnormalities such as changes due to brain tumor, brain hemorrhage, traumatic brain disease, or degenerative brain disease in brain MRI examination
n. People with severe physical illness (cancer, tuberculosis, etc.)
o. Those with sensitive skin diseases including contact skin diseases
p. If the researcher determines that it is inappropriate to participate in this study
- In case of non-cooperative participation in the experiment
- If you do not understand the explanation or have difficulty filling out the questionnaire
q. unacceptable concomitant medications
- Patients who have or are taking psychotropic drugs
- Treatment for chronic brain disease
r. Others
- Patients with high fever
- Patients with bleeding due to various surgeries, etc.
- Patients with cerebral edema
- If you have a history of convulsive seizures
- Patients with complications that may be risky to practice
- Other patients deemed inappropriate by the attending physician
- When using together with other electronic medical devices, you must obtain permission from your doctor.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of the effectiveness and safety of FUS on sleep qualities improvement by brain network analysis according to LIFU stimulation
- Secondary Outcome Measures
Name Time Method Differences in scores on questionnaires related to emotion (depression and anxiety scales), subjective and objective sleep qualities by actigraphy using mixed model analysis for statistics