Insomnia
Conditions
Interventions
Control group:The control group receives cognitive behavioral therapy (CBT), which systematically guides patients in learning sleep hygiene education, relaxation therapy, stimulus control, sleep restr
Hyperbaric oxygen therapy (HBOT) group:In addition to the control group intervention, patients undergo HBOT using a 40-person chamber (manufactured by Yantai Binglun, China). The chamber is pressurize
EEG Bioelectric Stimulation Group:In addition to the control group intervention, patients receive electroencephalographic biofeedback stimulation therapy (30 minutes per session, once daily, 5 days pe
Combination group:In addition to the control group intervention, patients receive combined HBOT and EEG bioelectric stimulation.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-70 years (inclusive), regardless of gender; 2.Suffering from sleep dysfunction with a Pittsburgh Sleep Quality Index (PSQI) score >5; 3.Meeting the diagnostic criteria for functional insomnia: (1) Complaints of difficulty falling asleep, difficulty maintaining sleep, or poor sleep quality; (2) Such sleep disturbances occur at least 3 times per week and persist for more than 1 month; (3) Excessive preoccupation with insomnia during daytime and nighttime, with undue concern about its consequences; (4) The dissatisfaction with sleep quantity and/or quality causes significant distress or impairs social/occupational function. 4.No use of antipsychotic or sedative-hypnotic medications in the past 2 weeks; 5.Willing to participate in this clinical trial and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with other sleep disorders such as excessive daytime sleepiness disorder, narcolepsy, sleep-related breathing disorders, sleep-wake rhythm disorders, non-rapid eye movement sleep arousal disorder, nightmare disorder, rapid eye movement sleep behavior disorder, restless legs syndrome, and substance/medication-induced sleep disorders; 2. Individuals with insomnia comorbid with other mental disorders such as depressive disorders or anxiety disorders; 3. Individuals with significant cognitive impairment or schizophrenia, or those with poor comprehension or communication skills who cannot adequately describe their insomnia condition; 4. Individuals with unstable vital signs and comorbid serious chronic diseases; 5. Individuals with intracranial implanted metal or electronic devices; 6. Individuals with cranial defects or those who have undergone metal cranial reconstruction surgery; 7. Patients with bleeding tendencies (e.g., acute cerebral hemorrhage, coagulation disorders) should be used with caution; 8. Patients with implanted electronic devices are contraindicated (e.g., pacemaker carriers); 9. Non-compliant individuals who cannot complete the course of treatment as required; 10. Individuals with contraindications related to hyperbaric oxygen therapy, such as pneumothorax, pulmonary bullae, emphysema, increased intracranial pressure, uncontrolled hypertension (above 160/100 mmHg), and unstable epilepsy; 11. Pregnant or breastfeeding women; 12. Individuals who have participated in other clinical trials within one month before the start of this trial; 13. Individuals deemed unsuitable for the clinical trial by the researchers for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score;Insomnia Severity Index;Flinders Fatigue ;Self-anxiety scale score;Safety Evaluation; | — |
Countries
China
Contacts
Public ContactHuang Cheng
West China Hospital, Sichuan University
Outcome results
None listed