Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838067
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-04-04
Brief Title:
Validation of Therapeutic Effects of Cefaly on Insomnia
Sponsor:
Saint Vincents Hospital Korea
Organization:
Saint Vincents Hospital Korea
Study Overview
Official Title:
Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses a Single Site Single-armed Exploratory Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Insomnia patients received a 20-minute daily sessions of the Cefaly for 4 weeks Primary endpoint was a reduction of scores in Pittsburgh Sleep Quality Index Insomnia Severity Index Epworth Sleepiness Scale improvements in polysomnography measures and changes in resting state networks cortical thickness fractional anisotropy and mean diffusivity
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 nonpharmacological treatment for insomnia is increasing emphasized due to reports of side effects and detrimental consequences of hypnotics Trigeminal nerve electrical neuromodulation has been suggested as a potential treatment modality through its modulation of noradrenergic activity that results in promoting relaxation and reducing hyperarousal Insomnia patients enrolled in the study will go through a 20-minute daily session of the Cefaly deviceoriginally FDA-approved device for migraine which electrically modulates trigeminal nerve for 4 weeks The objective of this study is to test whether trigeminal nerve electrical neuromodulation has a therapeutic effect validation measures involving subjective measuresPittsburgh Sleep Quality Index Insomnia Severity Index Epworth Sleepiness Scale objective measuresPolysomnography measures and neuroimagingchanges in resting state networks cortical thickness fractional anisotropy and mean diffusivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None