Insomnia
Conditions
Interventions
Treatment Group:Subjects were treated with MDSK-XBTI-PRO cognitive Behavioral therapy for insomnia
Sponsors
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18–65 years (inclusive), regardless of gender; (2) Meet the diagnostic criteria for insomnia disorder based on the DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) [The diagnostic criteria for insomnia disorder mainly include the following aspects: A. The individual reports dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: 1. Difficulty initiating sleep (in children, this may manifest as difficulty initiating sleep without caregiver intervention). 2. Difficulty maintaining sleep, characterized by frequent awakenings or trouble returning to sleep after awakenings (in children, this may manifest as difficulty returning to sleep without caregiver intervention). 3. Early morning awakening with inability to return to sleep. B. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. C. The sleep difficulty occurs at least three nights per week. D. The sleep difficulty has been present for at least three months. E. The sleep difficulty occurs despite adequate opportunity for sleep. F. The insomnia is not better explained by another sleep–wake disorder and does not occur exclusively during the course of another sleep–wake disorder (e.g., narcolepsy, breathing-related sleep disorder, circadian rhythm sleep–wake disorder, parasomnia). G. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication). H. Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.]; (3) ISI (Insomnia Severity Index) score >14; (4) PHQ-9 (Patient Health Questionnaire-9) score <=19; (5) GAD-7 (Generalized Anxiety Disorder-7) score <= 14; (6) Voluntarily participate in this clinical trial, with the ability to understand the study objectives, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of a known and diagnosed neurological or psychiatric disorder that may affect sleep within 6 months prior to signing the informed consent form, such as depressive disorder, bipolar disorder, epilepsy, schizophrenia spectrum and other psychotic disorders, or substance-related and addictive disorders; (2) Presence of a known and diagnosed physical disease that may affect sleep, such as congestive heart failure, acute exacerbation of COPD, or acute phase of cardiovascular or cerebrovascular diseases; (3) Presence of a known and diagnosed but untreated sleep disorder, such as sleep apnea or restless legs syndrome (RLS); (4) Hospitalization within the past month due to physical illness or severe mental disorder (excluding PSG sleep monitoring); (5) Currently exhibiting severe suicidal ideation, suicidal behavior, or severe psychotic symptoms, with a PHQ-9 item 9 score >= 2; (6) Previous experience with cognitive behavioral therapy for insomnia (CBT-I); (7) Participation in any other drug or medical device clinical trial within 3 months prior to signing the informed consent form; (8) Shift workers, long-term night workers, or frequent trans-time-zone travelers (e.g., international flight crew members); (9) Pregnant or lactating women, or women planning to become pregnant within the next six months; (10) STOP-Bang questionnaire score >= 3, indicating risk for obstructive sleep apnea-hypopnea syndrome; (11) Patients currently using implanted or external stimulator devices, such as cardiac pacemakers, deep brain stimulators, thalamic stimulators, vagus nerve stimulators, or transcranial magnetic stimulators; (12) Use of medications within the past month that could significantly induce insomnia; (13) Subjects deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index (ISI) score;Generalized Anxiety Disorder-7 (GAD-7) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index (ISI) score at Day 90 ± 5 days and Day 180 ± 5 days after completion of treatment;Pittsburgh Sleep Quality Index (PSQI) score;Epworth Sleepiness Scale (ESS) score;Patient Health Questionnaire-9 (PHQ-9) score;Device Performance Evaluation; | — |
Countries
China
Contacts
Public ContactLisan Zhang
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Outcome results
None listed