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Clinical Trials/KCT0007512
KCT0007512
Recruiting
未知

The effects of non-invasive focused ultrasound intervention for sleep and pilot study for safety/efficacy evaluation in sleep disorders

Ewha Womans University Medical Center0 sites45 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Ewha Womans University Medical Center
Enrollment
45
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Not specified

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