Sleep disorder
Conditions
Interventions
Control Group:Ultrasonic cervical lymph node stimulation sham intervention
Experimental Group:Ultrasound-stimulated intervention of cervical lymph nodes
Sponsors
Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 80 (inclusive), with no gender restrictions; 2. Meet the diagnostic criteria for insomnia as outlined in the International Classification of Sleep Disorders Third Edition (ICSD-3): (1). Subjective experience of sleep disturbance (reporting dissatisfaction with nighttime sleep, manifested as difficulty falling asleep, difficulty maintaining sleep, early awakening, unwillingness to go to bed at an appropriate time, or difficulty falling asleep without supervision); (2). Regular bedtime (sleep or attempted sleep time) between 6-9 hours, with adequate sleep duration and sleep environment; (3). At least one daytime symptom: fatigue, irritability, decreased work/study/social ability, etc. 3.Currently receiving benzodiazepine treatment for sleep disorders, with a cumulative treatment duration of >=3 months, and a strong willingness to reduce medication; 4. Able to understand the research process, willing to comply with the requirements of the research protocol, and cooperate in completing the intervention measures and follow-up assessments; 5. Volunteer to participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Acute phase of neurological diseases: Patients with severe neurological diseases in the acute phase within 3 months before enrollment (or during the study period), including but not limited to cerebral infarction, cerebral hemorrhage, status epilepticus, and craniocerebral injury; 2.Clinically significant history of neurological diseases: History of neurological diseases that, as determined by the investigator, may affect the execution of the study or safety evaluation, including but not limited to: (1). Previous history of seizures (excluding febrile seizures), which may be induced by benzodiazepine withdrawal; (2). History of head trauma: having a clearly diagnosed cranial injury, post-concussion syndrome, or post-traumatic epilepsy within 2 years prior to enrollment; (3).Previous history of brain surgery: including craniotomy, deep brain stimulation implantation, etc; 3. Acute phase of mental illness: Currently experiencing an acute episode of severe mental illness (such as schizophrenia, bipolar disorder, major depressive disorder with suicide risk, substance abuse dependence, severe anxiety disorder, etc.), or requiring emergency psychiatric intervention; 4.Clinically significant history of psychiatric disorders: History of psychiatric disorders that, as determined by the investigator, may affect study compliance or safety, including but not limited to: (1). any previously diagnosed schizophrenia or schizoaffective disorder; (2). any previously diagnosed bipolar disorder; (3). major depressive disorder: history of recurrent episodes, accompanied by a history of suicidal behavior or requiring hospitalization; (4).history of dependence on substances such as alcohol, opioids, and cocaine (excluding nicotine) within the past 2 years; (5). severe anxiety disorder: including panic disorder, generalized anxiety disorder with significant functional impairment, and not having been stably controlled in the recent period; (6). obsessive-compulsive disorder: currently or previously experiencing severe obsessive-compulsive symptoms affecting daily functioning. 5. Severe physical illness: The presence of severe or unstable systemic diseases that, in the judgment of the researcher, may affect the execution of the study, such as unstable angina pectoris, severe hepatic and renal insufficiency, respiratory failure, etc; 6. Active infection/inflammation: Subjects with active infection or systemic inflammatory disease that, in the investigator's judgment, may significantly interfere with laboratory test results; 7.Contraindications for equipment use: There are clear contraindications for the intervention equipment in this study, including but not limited to: (1). individuals with damaged skin, rashes, allergies, or infections on the neck; (2). individuals with implanted active electronic devices (such as cardiac pacemakers, vagus nerve stimulators, etc.); (3). women who are pregnant or in the preparation phase for pregnancy; 8. Severe Obstructive Sleep Apnea Syndrome: Severe Obstructive Sleep Apnea Syndrome diagnosed during the screening period or previously; 9. Peri-menopausal-related sleep disorders: Researchers have determined that sleep disorders are primarily caused by peri-menopausal syndrome; 10. Known to be HIV-positive and infected with syphilis; 11.Other researchers' judgment: In any other circumstances (such as cognitive dysfunction, planning to relocate in the near future, etc.), researchers believe that it may put study participants a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of benzodiazepine tapering;Adverse event occurrence rate (%) and frequency of occurrence (number of events); | — |
Secondary
| Measure | Time frame |
|---|---|
| Daytime function;Benzodiazepine withdrawal rate;Emotional state;Benzodiazepine reduction rate;The incidence of drug reduction reactions and the incidence of moderate to severe drug reduction reactions;Incidence rate (%) and frequency (number of events) of serious adverse events;Incidence rate (%) and frequency (number of events) of device-related adverse events;The occurrence rate (%) and frequency (number of events) of device defects;Sleep quality score, Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI);Quality of life;Incidence rate of device-related serious adverse events (%) and Frequency of occurrence (number of events);Neurodegenerative related biomarkers;Objective indicators of sleep structure; | — |
Countries
China
Contacts
Public ContactHaishui Duan
Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)
Outcome results
None listed