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Investigating the value of heart rate variability under auditory stimulation as an aid to diagnosis in patients with chronic disorders of consciousness

Investigating the value of heart rate variability under auditory stimulation as an aid to diagnosis in patients with chronic disorders of consciousness

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068341
Enrollment
Unknown
Registered
2023-02-15
Start date
2023-02-15
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

disorder of consciousness

Interventions

Gold Standard:the Coma Recovery Scale–Revised Scale,CRS-R
Index test:heart rate variability

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. inclusion criteria for patients with chronic disorders of consciousness (1) met the diagnostic criteria for chronic disorders of consciousness with a duration of >28 days; (2) were between 18 and 80 years of age, regardless of gender; (3) were not taking neuromuscular blockers or sedatives within 24 hours; (4) had an auditory evoked potential test MMN wave amplitude >0.6 µV and <3 µV; (5) had an eye opening period (indicating waking and resting cycles). (6) No professional music training; (7) Patient's family members were voluntary and informed, signing the informed consent form. 2. Inclusion criteria for healthy subjects (1) age matched to the patient, between 18 and 80 years old, regardless of gender; (2) good health, no history of circulatory, neurological, psychiatric abnormalities and metabolic abnormalities; (3) full civil capacity; (4) subjects voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Exclusion criteria for patients with chronic disorders of consciousness (1) previous history of atrial fibrillation, cardiac surgery, or betalactam; (2) severe hearing impairment; (3) persistent exacerbation and uncontrolled active cerebral hemorrhage. 2. Exclusion criteria for healthy subjects (1) previous history of atrial fibrillation, cardiac surgery, or betalactam; (2) history of mental illness, substance abuse, or drug dependence; (3) auditory disorders; (4) those who had consumed excessive (more than 8 cups per day, 250mL per cup) tea, coffee or caffeinated beverages in the previous 6 months; those who had consumed any beverage or food containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48h before the start of the test; (5) those who had a high level of musical literacy or had worked in music-related jobs; (6) those who had a positive pregnancy test or were breastfeeding.

Design outcomes

Primary

MeasureTime frame
heart rate variability;heart rate variability;Sensitivity;Specificity;Accuracy;Youden Index,YI;positive likelihood ratios,LR+;negative likehood ratios, LR-;CRS-R scale scores;

Countries

China

Contacts

Public ContactYulong Wang

Shenzhen Second People's Hospital

ylwang66@163.com13923448395

Outcome results

None listed

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