Status:
COMPLETED
Validation of Therapeutic Effects of Cefaly on Insomnia
Lead Sponsor:
Saint Vincent's Hospital, Korea
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
19-64 years
Phase:
NA
Brief Summary
The study aims to examine whether the Cefaly has a therapeutic effect on insomnia patients visiting a psychiatric clinic in Korea. The study design is a single site, single-armed exploratory study. In...
Detailed Description
Insomnia is well-known for its association with adverse health outcomes. Although insomnia is usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for novel nonpharmac...
Eligibility Criteria
Inclusion
- Patients who have adequately understood the whole study procedures within age range of 19-64 years
- Patients with insomnia severity index (ISI) score of more than 15
Exclusion
- Cognitive impairment
- Psychiatric disorders or neurological disorders.
- Unstable medical conditions
- Prior diagnosis of sleep disorders
- Hypnotic prescription
- History of brain or facial trauma within 3 months
- Skin abrasions
- Acrylic acid allergy
- Electromagnetic hypersensitivity
- Apnea hypopnea index of \>15/hour in the baseline polysomnography.
Key Trial Info
Start Date :
July 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04838067
Start Date
July 26 2018
End Date
July 14 2020
Last Update
April 8 2021
Active Locations (1)
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1
St.Vincent's Hospital, the Catholic University of Korea
Suwon, South Korea