Chronic Insomnia Disorder
Conditions
Keywords
suanzaoren decoction, eszopiclone, polysomnography
Brief summary
The purpose of this study is to observe the cognitive function and clinical efficacy of modified Suanzaoren decoction and eszopiclone in the treatment of chronic insomnia disorder patients, and to investigate the possible neural mechanisms using MRI techniques.
Detailed description
The subjects were enrolled and divided into two treatment groups using the randomized numeric table method. Each group received either modified Suanzaoren decoction or eszopiclone treatment for a period of 4 weeks. General demographic data were collected, and changes in sleep, mood, cognitive function, and rs-fMRI before and after treatment were observed. Assessment tools included the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Hamilton Anxiety Scale (HAMA), and Hamilton Depression Scale (HAMD) for subjective measures, as well as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and polysomnography (PSG) for objective evaluation.
Interventions
DRUGsuanzaoren decoction
The Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver
DRUGEszopiclone 1 mg
Eszopiclone is used in the treatment of various types of insomnia.
Sponsors
The Third Hospital of Inner Mongolia Autonomous Region
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have adequate comprehension ability, with at least 9 years of education. * Western medical diagnosis criteria (meeting the diagnostic criteria for chronic insomnia disorder in ICSD-3). * Patient's subjective dissatisfaction with either the total duration or quality of sleep: difficulty falling asleep, difficulty maintaining sleep, or early awakening. * Frequency of sleep problems: occurring at least 3 nights per week, and persisting for at least 3 months.
Exclusion criteria
* Individuals who have used sedatives or hypnotics, or psychiatric medications in the week prior to enrollment. * Individuals who regularly consume strong tea, have a high smoking volume, or are dependent on coffee. * Women who are pregnant or breastfeeding. * Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, other mental disorders, or severe obstructive sleep apnea syndrome. * Individuals with allergies or multiple drug allergies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index | 4 weeks | The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire that assesses sleep quality and disturbances over a one-month time interval. It consists of 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The sleep condition before and after treatment is reflected using polysomnography | 4 weeks | Polysomnography is a comprehensive test used to diagnose sleep disorders. It records various body functions during sleep, including brain waves, eye movements, muscle activity, heart rhythm, and breathing patterns. This information helps clinicians evaluate sleep quality and diagnose sleep disorders such as sleep apnea, insomnia, and REM behavior disorder. |
| The depression condition before and after treatment is evaluated by Hamilton Depression Rating scale | 4 weeks | The Hamilton Depression Rating Scale is a widely used tool to measure the severity of depression in individuals. It consists of 17 items that assess various symptoms of depression, such as mood, guilt, suicidal thoughts, and sleep disturbances. Each item is scored based on the severity of the symptom, and the total score indicates the overall severity of depression, with higher scores indicating more severe depression. |
| The anxiety condition before and after treatment is evaluated by Hamilton Anxiety Rating scale | 4 weeks | The Hamilton Anxiety Rating Scale (HAM-A) is a widely used tool for assessing the severity of anxiety symptoms in individuals. It consists of 14 items that measure various aspects of anxiety, including psychological, physical, and behavioral symptoms. |
| The cognition function before and after treatment is evaluated by Repeatable Battery for the Assessment of Neuropsychological Status | 4 weeks | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a widely used neuropsychological assessment tool designed to evaluate cognitive function across various domains. It consists of 12 subtests that assess attention, language, visuospatial/constructional abilities, and immediate and delayed memory. |
Countries
China
Outcome results
None listed