Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290492
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-12-28
Brief Title:
Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia
Sponsor:
WANG KAI
Organization:
Anhui Medical University
Study Overview
Official Title:
Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia
Status:
RECRUITING
Status Verified Date:
2023-12
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:
To investigate the intervention effect of transcranial direct current stimulation tDCS on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients
Detailed Description:
Fifty patients with chronic insomnia disorder diagnosed by the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia 2017 were recruited from the first affiliated Hospital of Anhui Medical University After meeting the inclusion criteria and obtaining informed consent each participant will complete the subjective measures consisting of sleep questionnaires polysomnography PSG and tDCS treatment conducted by trained researchers at the Neurology Department of Anhui Medical University All the participants were randomized 11 to receive active or sham treatment protocol The anode electrode was placed on the DMPFC Fz surrounded by four cathodes with a 1cm diameter FPz F3 Cz and F4 Each participant received 30 min of tDCS stimulation once daily for 10 consecutive days The stimulation direct current magnitude was set at 2 mA in the active group In the sham intervention phase the sensation was simulated by applying a 30s rising current until 2 mA was reached with a 30s immediate decline at the beginning and end of each phase
At the beginning and after a 10-day intervention subjective measures consisting of sleep questionnaires including the Pittsburgh Sleep Quality Index PSQI and Insomnia Severity Index ISI were assessed The Flinders Fatigue Scale FFS and the Epworth Sleepiness Scale ESS were used to assess daytime sleepiness Additionally the HAMA and HAMD were used synchronously for emotional assessment Afterwards they were unblinded by the study coordinator
At the beginning and after a 10-day intervention subjective measures consisting of sleep questionnaires including the Pittsburgh Sleep Quality Index PSQI and Insomnia Severity Index ISI were assessed The Flinders Fatigue Scale FFS and the Epworth Sleepiness Scale ESS were used to assess daytime sleepiness Additionally the HAMA and HAMD were used synchronously for emotional assessment Afterwards they were unblinded by the study coordinator
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?:
False
Is an FDA AA801 Violation?:
None