insomnia disorder
Conditions
Interventions
Treatment Group:The subjects in the Treatment group received routine treatment (sleep hygiene education+medication treatment) combined with sleep disorder adjuvant treatment software (normal use) for
Control Group:The control group subjects received routine treatment (sleep hygiene education+medication treatment) combined with sleep disorder adjuvant treatment software (by changing the VR playback
Sponsors
Xiangya Second Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender; 2. Patients whose clinical diagnosis meets the diagnostic criteria for insomnia in the International Classification of Sleep Disorders Third Edition (ICSD-3) and whose Pittsburgh Sleep Quality Index (PSQI) score is = 8; 3. Patients who can adapt to virtual reality (VR) devices and are willing to receive VR device treatment; 4. The patient has autonomy, clear consciousness, no intellectual or behavioral disorders, and is able and willing to cooperate with treatment; 5. The patient voluntarily participates in the study and is willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with epilepsy and severe VR dizziness; 2. Pregnant or lactating women; 3. Those with severe liver or kidney dysfunction, or those with severe diseases of various systems; 4. Patients who have taken any psychotropic drugs or other drugs known to affect sleep within the past 2 weeks, or are expected to require any such drugs during treatment; 5. Patients who have previously used zopiclone or right zopiclone therapy but have not been treated effectively; 6. Patients engaged in shift work; 7. Individuals who are known to be allergic to psychotropic drugs or other known sleep affecting drug components; 8. Patients with severe anxiety disorder, i.e. those with a Self Rating Anxiety Scale (SAS) score greater than 69 points; 9. Patients with severe depression, i.e. those with a Self Rating Depression Scale (SDS) score greater than 72 points; 10. Those who have participated in clinical trials of other drugs within 3 months or other medical devices within 30 days; 11. Other situations where the investigator deems it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effectiveness after 2 weeks of treatment;Improvement in Pittsburgh Sleep Quality Index (PSQI) after 2 weeks of treatment finished, compared to basement.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment effectiveness after 2 weeks of treatment finished;Treatment effectiveness after 4 weeks of treatment finished;Improvement in Pittsburgh Sleep Quality Index (PSQI) after 2 weeks of treatment compared to basement.;Improvement in Pittsburgh Sleep Quality Index (PSQI) after 4 weeks of treatment finished, compared to basement.;Improvement in Sleep Quality after 2 weeks of treatment;Improvement in Sleep Quality after 2 weeks of treatment finished.;Improvement in Sleep Quality after 4 weeks of treatment finished.;Improvement in Self Rating Depression Scale (SDS) after 2 weeks of treatment , compared to basement.;Improvement in Self Rating Depression Scale (SDS) after 2 weeks of treatment finished, compared to basement.;Improvement in Self Rating Depression Scale (SDS) after 4 weeks of treatment finished, compared to basement.;Improvement in Self Rating Anxiety Scale (SAS) after 2 weeks of treatment compared to basement.;Improvement in Self Rating Anxiety Scale (SAS) after 2 weeks of treatment finished, compared to basement.;Improvement in Self Rating Anxiety Scale (SAS) after 4 weeks of treatment finished, compared to basement.;Medical Equipment performance evaluation; | — |
Countries
China
Contacts
Public ContactLiwen Tan
The Second Xiangya Hospital of Central South University
Outcome results
None listed