Chronic Insomnia Disorder
Conditions
Interventions
treatment group :The subjects received adjuvant treatment software for chronic insomnia once a day, requiring a total of 28 treatments.
Sponsors
Hangzhou Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? Participants with primary insomnia as defined by the diagnostic criteria of chronic insomnia disorder in the International Classification of Sleep Disorders edition 3 (ICSD-3); ? Participants with Insomnia severity index (ISI) score =8; ? Primary insomnia duration at least3 months; ? Participants aged 18 to 65 years old (including 18 and 65 years old), male or female; ? Participants with capacity to handle smart devices (such as smart phones, tablets, computers, etc.), and know how to use softwares, such as wechat; ? Participants understanding the procedures and methods of the trial, is willing to complete the trial in accordance with the protocol and sign the informed consent form.
Exclusion criteria
Exclusion criteria: ? Female participants who are pregnant or lactating, or who plan to be pregnant during the trial ? Participants with a previous or current diagnosis of other mental disorders (e.g., anxiety disorders, depressive episodes, etc.) ? Participants with previous or current diagnosis of severe sleep apnea, heart failure, myocardial infarction, stroke, cancer, severe pulmonary disease, neurodegenerative diseases (such as Parkinson's disease, dementia, etc.), epilepsy, restless legs syndrome, etc ? Participants who are using a variety of stimulator devices, such as cardiac pacemakers, brain depth stimulators, thalamic stimulators, vagus nerve stimulators, and transcranial magnetic stimulators ? Participants received psychotherapy for insomnia in the past one month ? Shift workers and/or frequent flyers across time zones ? Participants administrated any psychotropic drugs or drugs known to affect sleep in the past one month ? Participants in a drug clinical trial in the past 3 months , or any other clinical trials of medical device in the past 30 days ? Other conditions that are not eligible for the trial judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Epworth Sleeping Scale ;Generalized Anxiety Disorder 7-item(GAD-7);Patient Health Questionnaire-9(PHQ-9);Total Sleep Time(TST);Sleep Onset Latency(SOL);Wake After Sleep Onset(WASO);Number of Awakenings(NWAK); | — |
Countries
China
Contacts
Public ContactMao Hongjing
Hangzhou Seventh People's Hospital
Outcome results
None listed