Severe Sleep Disorder
Conditions
Interventions
Anesthesia-Induced Combined TMS Group:Anesthesia-Induced Combined TMS
Anesthesia Induction Group:Low-dose dexmedetomidine for anesthesia induction and sleep rhythm regulation
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18–80 years with severe sleep disorder; 2.Insomnia Severity Index (ISI) score >= 22; 3.Polysomnography (PSG) shows sleep efficiency (SE) < 65%; 4.Disease duration of more than 6 months; 5.Unresponsive or intolerant to at least two first-line treatments (e.g., cognitive behavioral therapy for insomnia [CBT-I], melatonin receptor agonists), defined as minimal symptom improvement or inability to tolerate after 6–8 weeks of conventional therapy; 6.Patients who have been explained the study purpose and have provided informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with severe systemic diseases; 2.Patients diagnosed with depression or anxiety, or with a Hospital Anxiety and Depression (HAD) scale score = 11; 3.Patients allergic to any required medications; 4.Patients with second- or third-degree atrioventricular block or bradycardia (heart rate < 50 bpm) on electrocardiogram prior to treatment; 5.Patients with morbid obesity, thyromental distance < 6.5 cm, mouth opening < 3 finger breadths, or severe OSA; 6.Patients with metal implants (e.g., metal plates, clips, electrodes, chips, pumps, stimulators, cochlear implants, pacemakers); 7.Patients participating in other clinical trials within the past 3 months; 8.Patients with hearing and/or speech communication impairments; 9.Pregnant patients; 10.Patients with a personal or family history of epilepsy; 11.Patients with a history of syncope; 12.Patients with severe headaches; 13.Patients taking psychiatric medications for reasons other than insomnia; 14.Other conditions deemed inappropriate for study participation by the investigator based on individual assessment; 15.Patients who refuse to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI Reduction Rate;Improvement in PSG Sleep Efficiency;ISI Reduction Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug Name and Dosage of the Administered Medication;Plasma levels of IL-1, IL-6, TNF-a, 5-HT, DA, NE, melatonin, GABA, and glutamate.;Incidence of Adverse Events;Improvement in PSG Sleep Efficiency;Incidence of Serious Adverse Events;Changes in fMRI Functional Connectivity;General Demographic Information;PSQI Reduction Rate;the Score of Hospital anxiay and depression scale;ISI Reduction Rate; | — |
Countries
China
Contacts
Public ContactJinbao Li
Shanghai General Hospital
Outcome results
None listed