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Observation on the Efficacy of Digital Therapeutics for Insomnia Related to Emotions after Acute Cerebral Infarction

Observation on the Efficacy of Digital Therapeutics for Insomnia Related to Emotions after Acute Cerebral Infarction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109434
Enrollment
Unknown
Registered
2025-09-18
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Insomnia, anxiety or depressive state after acute cerebral infarction

Interventions

Conventional treatment group for cerebral infarction:Conventional treatment for cerebral infarction
Conventional treatment for cerebral infarction + digital therapy treatment group:Digital therapeutics

Sponsors

Beijing Friendship Hospital Pinggu Campus,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for acute ischemic stroke, with an onset time of = 7 points. 5.The Hamilton Depression Rating Scale (HAMD) score is >= 7 and = 7 and < 21. 6.The patient voluntarily participated with full knowledge and signed the informed consent form; 7.The subjects can use electronic devices or have other relatives guide them in using the electronic devices.

Exclusion criteria

Exclusion criteria: 1.Hearing loss, color vision deficiency, illiteracy or other conditions that prevent the completion of training. 2.There is a history of other neurological disorders, such as traumatic brain injury, dementia, Parkinson's disease, epilepsy, etc. 3.Drug or alcohol abuse or dependence; 4.Sleep disorders associated with mental disorders, such as major depressive disorder and generalized anxiety disorder, with HAMD scores > 24 or HAMA >= 21, or with suicidal tendencies, and schizophrenia. 5.Combining other sleep disorders, such as sleepwalking, obstructive sleep apnea syndrome, and rapid eye movement (REM) sleep behavior disorder. 6.Shift workers; 7.Infarction in special areas (thalamus, brainstem);

Design outcomes

Primary

MeasureTime frame
The scores of the digital therapy group were lower than those of the control group.;

Secondary

MeasureTime frame
The incidence rate of any adverse events;The scores of the digital therapy group improved more significantly compared to the control group.;After 12 weeks of intervention, the scores of ISI, MoCA, HAMD, HAMA, NIHSS and mRS in the intervention group changed compared to the baseline.;The improvement in sleep onset time and sleep efficiency after 12 weeks of intervention compared to the baseline level;

Countries

China

Contacts

Public ContactGao Wei

Beijing Friendship Hospital Pinggu Campus,Capital Medical University

1551041864@qq.com+86 10 8999 9014

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026