Insomnia, Psychophysiological
Conditions
Brief summary
Effect of transcranial current stimulation on insomnia disorder
Detailed description
Insomnia disorder represents a prevalent clinical challenge, transcranial current stimulation has emerged as a promising noninvasive therapeutic approach; however, its specific effects on neurophysiological mechanisms underlying sleep-related brain structure and functional change, and neurobiological change remain unclear.
Interventions
consecutive daily 20-min, 1.1-mA sessions
DEVICESham stimulation
only wore the device and had no stimulation
Sponsors
Zan Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of insomnia disorder * Cooperate to complete the questionnaire surveys
Exclusion criteria
* Presence of mental disorders * Current use of central nervous system stimulants * Use of analgesics,sedatives or hypnotic medications, theophylline preparations, steroid medications * Alcohol abuse or regular alcohol consumption * Diagnosis of other sleep disorders, including obstructive sleep apnea, rapid eye movement sleep behavior disorder, or restless legs syndrome * Sleep disorders secondary to organic diseases, such as epilepsy, diabetes, or renal failure * Shift work or irregular work schedules that disrupt normal circadian rhythms * Use of medications affecting central nervous system function within the past one month * Recent sleep-related confounding behaviors within the past two weeks, including staying up late, alcohol consumption, or smoking * Presence of organic brain lesions on head MRI and contraindications to MRI examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in global blood-oxygen-level-dependent (gBOLD) signal amplitude | 2 weeks and 3 months | The amplitude of the global blood-oxygen-level-dependent (gBOLD) signal was derived from resting-state functional MRI and reflects the overall magnitude of spontaneous brain activity. Unit of Measure: Z-score |
| Change in resting-state functional connectivity strength | 2 weeks and 3 months | Resting-state functional connectivity strength was calculated as the correlation coefficient between predefined brain regions based on functional magnetic resonance imaging data. |
| Change in amplitude of low-frequency fluctuations | 2 weeks and 3 months | Amplitude of low-frequency fluctuations was calculated from resting-state fMRI to quantify spontaneous neural activity. |
| Change in regional homogeneity | 2 weeks and 3 months | Regional homogeneity was used to assess the synchronization of local spontaneous brain activity |
| Change in phase difference of dynamic cerebral autoregulation | 2 weeks and 3 months | Dynamic cerebral autoregulation was assessed using the phase difference between cerebral blood flow velocity and arterial blood pressure fluctuations. Larger phase differences indicate better autoregulatory function. |
| Change in gain of dynamic cerebral autoregulation | 2 weeks and 3 months | Gain represents the magnitude of cerebral blood flow velocity changes in response to blood pressure fluctuations, with lower gain values indicating more effective autoregulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the score of Insomnia Severity Index scale | 2 weeks and 3 months | The total score ranges from 0 to 28, and a higher score indicates higher levels of insomnia severity. A score of 8 or greater is the cut point for clinically possible insomnia |
| the score of 14-item Hamilton anxiety rating scale | 2 weeks and 3 months | The total score ranges from 0 to 56, and a higher score indicates higher levels of anxiety symptoms. A score of 7 or greater is the cut point for clinically possible anxiety |
| the score of 17-item Hamilton depression rating scale | 2 weeks and 3 months | tThe total score ranges from 0 to 52, and a higher score indicates higher levels of depression symptoms. A score of 7 or greater is the cut point for clinically possible depression symptom |
| Change in plasma corticotropin-releasing factor (CRF) level | 2 weeks and 3 months | Plasma corticotropin-releasing factor (CRF) concentration was measured as a biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity. Higher levels indicate increased neuroendocrine stress response. Unit of Measure: pg/mL |
| Change in plasma cortisol level | 2 weeks and 3 months | Plasma cortisol concentration was assessed as an indicator of hypothalamic-pituitary-adrenal (HPA) axis function. Higher levels reflect increased physiological stress response. Unit of Measure: μg/dL |
| Change in serum interleukin-6 level | 2 weeks and 3 months | Serum interleukin-6 concentration was measured as a marker of systemic inflammation. Higher levels indicate greater inflammatory activity. Unit of Measure: pg/mL |
| Change in serum brain-derived neurotrophic factor level | 2 weeks and 3 months | Serum brain-derived neurotrophic factor concentration was measured as a biomarker associated with neuroplasticity and neuronal function. Higher levels indicate enhanced neurotrophic activity. Unit of Measure: pg/mL |
| Change in total sleep time (TST) measured by polysomnography | 2 weeks and 3 months | — |
| Change in sleep onset latency (SOL) measured by polysomnography | 2 weeks and 3 months | — |
| Change in wake after sleep onset (WASO) measured by polysomnography | 2 weeks and 3 months | — |
Countries
China
Contacts
CONTACTZan Wang, MD, PhD
Outcome results
None listed