Insomnia disorder
Conditions
Interventions
Experimental group:Patients will continue their existing pharmacological therapy for insomnia disorder while simultaneously receiving intervention with the multimodal sleep therapy device. The treatme
as well as application of infrared heat or hermal patches over the stellate ganglion.
Control group:The control group will continue their existing pharmacological treatment for insomnia disorder.
Sponsors
The Third People's Hospital of Chengdu
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pittsburgh Sleep Quality Index (PSQI) score > 7; 2. Aged between 18 and 75 years; 3.Voluntarily participate in the study and provide informed consent.
Exclusion criteria
Exclusion criteria: 1.Presence of neurological disorders, psychiatric disorders, language barriers, cognitive impairments, or other conditions affecting sleep quality; 2.History of malignant tumors; 3.Severe dysfunction of the heart, liver, lungs, or kidneys; 4.Inability to comply with or cooperate during sleep device monitoring.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroencephalogram (EEG) (F4/M1, O?/M1, C4/M1, F3/M2, C3/M2, O1/M2), sleep efficiency, arousal index, rapid eye movement (REM) sleep percentage, and sleep percentages for non-rapid eye movement (NREM) sleep Stage 1 (N1), Stage 2 (N2), and Stage 3 (N3).;Scores on the Pittsburgh Sleep Quality Index (PSQI) ;Patient Health Questionnaire-9 (PHQ-9).; | — |
Countries
China
Contacts
Public ContactChen Yong
The Third People's Hospital of Chengdu
Outcome results
None listed