Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia

Chronic Insomnia Clinical Trial

Official title:

Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290492
• Other study ID #: AHMU-tDCS-insomnia
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: Anhui Medical University
• Contact: Kai Wang, PhD
• Phone: +86-0551-62923704
• Email: baiyunong1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (1:1) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

1. age between 15 and 65 years,

2. diagnosed with chronic insomnia based on the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017),

3. no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.

Exclusion Criteria:

1. diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REM behaviour disorder, and restless legs syndrome,

2. history of head trauma or presence of serious organic diseases,

3. presence of comorbid anxiety or depression, as assessed by a Hamilton Anxiety Scale [HAMA] score of 17 or Hamilton Depression Scale [HAMD] score of 14.

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders
• Transcranial Direct Current Stimulation

Intervention

Device:
• transcranial direct current stimulation
tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, direct current applied directly to the head through scalp electrodes
• sham transcranial direct current stimulation
Sham tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
WANG KAI

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective sleep quality assessed by the PSQI	The Pittsburgh Sleep Quality Index (PSQI) consist of 18 items divided into 7 dimensions, such as sleep duration, sleep efficiency, sleep disorders and daytime dysfunction. The PSQI total score ranges from 0 to 21, the higher the score indicates the more worse sleep quality.	before and after 10-day intervention
Primary	subjective sleep quality assessed by the ISI	The Insomnia Severity Index (ISI) is a 7-item scale to measure insomnia symptoms, where each item is rated on a scale from 0 to 4. The ISI total score ranges from 0 to 28, The higher the score indicates the more worse sleep quality.	before and after 10-day intervention
Primary	daytime sleepiness assessed by the FFS	the Fatigue Severity Scale (FFS) is a 7-item scale to measure daytime sleepiness, where each item is rated on a scale from 0 to 3. The FFS total score ranges from 0 to 31, the higher the score indicates the more serious daytime sleepiness.	before and after 10-day intervention
Primary	daytime sleepiness assessed by the ESS	The Epworth Sleepiness Scale (ESS) is a 8-item scale to measure daytime sleepiness, where each item is rated on a scale from 0 to 3. The ESS total score ranges from 0 to 23, the higher the score indicates the more serious daytime sleepiness.	before and after 10-day intervention
Primary	objective sleep quality assessed by the PSG	the change of objective sleep quality assessed by polysomnography(PSG) will constitute the major research outcome measure, to assess response to tDCS. Recorded details included data on SOL(sleep onset latency), TST(total sleep time), WASO(wake after sleep onset), EF(sleep Efficiency), and percentages of slow-wave sleep, stage 2 sleep, stage 1 sleep, and REM sleep.	before and after 10-day intervention
Secondary	emotional symptoms assessed by the HAMA	The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.	before and after 10-day intervention
Secondary	emotional symptoms assessed by the HAMD	The HAMD is a clinic ian-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.	before and after 10-day intervention