insomnia disorder
Conditions
Interventions
intervention group:Study duration: 4 weeks. Participants will wear a heart rate monitoring device 5 days a week before bedtime. They will engage in 20-minute auditory biofeedback training sessions gui
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1)Age: 20-45 years old, gender unrestricted; 2)Target Population: Individuals diagnosed with insomnia disorder based on the diagnosis criteria of DSM-5; 3)Possess adequate communication and comprehension abilities; 4)Have signed informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients diagnosed with mental or physical comorbidities, or other sleep disorders according to the diagnostic criteria of DSM-5; 2)Pregnant or pre-pregnant females; 3)Individuals using sleep aids and/or nutritional supplements; 4)Patients suffering from acute cardiovascular and cerebrovascular conditions such as acute myocardial infarction, acute rapid arrhythmias, pulmonary edema, severe aortic valve stenosis, etc.; 5)Individuals with severe respiratory ailments such as asthma, chronic obstructive pulmonary disease (COPD), restricted lung capacity (due to obesity, pregnancy, or spinal deformities), or cystic fibrosis; 6)Endocrine and metabolic disorders, including hyperthyroidism, liver failure, and kidney diseases, etc.; 7)Neuromuscular diseases and degenerative conditions, such as muscular dystrophy, spinal muscular atrophy, and dementia, etc.; 8)Movement and other neurological disorders, such as Huntington's disease, dystonia, Parkinson's disease, and epilepsy disorders; 9)Patients with skin diseases or injuries around the device measurement sites; 10)Individuals with allergic predispositions, etc.; 11)Participants currently involved in drug or medical device clinical trials; 12)Individuals refusing to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sleep efficiency;GAD-7; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Epworth sleepiness score;PHQ-9; | — |
Countries
China
Contacts
Public ContactPeng Wang
Fuwai Hospital Chinese Academy of Medical Sciences
Outcome results
None listed