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Research and Development of Audio-Visual Fusion Sleep Therapy Devices Based on the 'Daylight and Night Darkness' Theory

Research and Development of Audio-Visual Fusion Sleep Therapy Devices Based on the 'Daylight and Night Darkness' Theory

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000997
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Treatment group:Sound and Light Therapy
Waiting Treatment Group:None

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine (Fangcun Sleep Disorders Department)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Age 18-65 years; (2)Meet Western medicine diagnostic criteria for chronic insomnia; (3)Meet TCM diagnostic criteria for insomnia; (4)Sign informed consent

Exclusion criteria

Exclusion criteria: 1)Contraindications or allergies to light therapy; 2) Individuals planning pregnancy, currently pregnant, or lactating; 3) Secondary insomnia caused by other diseases confirmed by medical history and consultation (e.g., localized pain, restless legs syndrome, acute/chronic heart failure, COPD, acute/chronic bronchitis); 4) Severe depression (PHQ-9 total score =15); 5) Severe anxiety (GAD-7 total score =15); 6) Severe insomnia (ISI total score =22); 7) Participation in other drug clinical trials within 30 days; 8) Comorbid psychiatric disorders

Design outcomes

Primary

MeasureTime frame
Pittsburgh Insomnia Rating Scale;

Secondary

MeasureTime frame
Insomnia Severity Index Scale;Generalized Anxiety Disorder Scale (GAD-7);Patient Health Questionnaire-9;

Countries

China

Contacts

Public ContactXu Biyun

Guangdong Provincial Hospital of Chinese Medicine

cloudxby@163.com13632399892

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026