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Effects of auditory closed-loop stimulation on autonomic nervous system in heart failure patients with insomnia

Effects of auditory closed-loop stimulation on autonomic nervous system in heart failure patients with insomnia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022441
Enrollment
Unknown
Registered
2019-04-11
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

Heart failure and sleep disorder

Interventions

case group:auditory closed-loop stimulation
control group:auditory closed-loop sham stimulation

Sponsors

the First Affiliated Hospital of Xinxiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Enrolled patients with simple heart failure and heart failure complicated with insomnia were determined according to the Chinese guidelines for the diagnosis and treatment of heart failure 2014 and the international guidelines for the classification of sleep disorders (icsd-3). (1) middle-aged male patients aged 45-65 years; (2) patients with definite diagnosis of systolic heart failure with stable clinical symptoms for nearly 1 month; (3) New York cardiac function classification (NYHA classification) is class II or III; (4) left ventricular ejection fraction (LVEF) 40% (judged by echocardiography); (5) patients who have received standard basic treatment for chronic heart failure and have reached the target dose or the maximum tolerance for more than 1 month, or have not changed the dose for nearly 1 month; (6) at least one or more insomnia symptoms exist, and insomnia cannot be explained by other sleep disorders.

Exclusion criteria

Exclusion criteria: (1) acute heart failure caused by acute coronary syndrome, acute myocarditis and pulmonary infarction; (2) patients with severe infection, anemia and liver and kidney insufficiency; (3) patients with chronic heart failure with acute hemodynamic disorder or acute decompensation; (4) patients with contraindications to mri such as pacemaker or defibrillator; (5) patients diagnosed with depression and other mental diseases; (6) other sleep related diseases, such as sleep apnea hypopnea syndrome, restless legs syndrome and periodic limb movement disorder, were excluded.

Design outcomes

Primary

MeasureTime frame
Heart rate variability;Blood pressure variability;Sympathetic skin response;Blood pressure;R-R internal variation;HR;EEG;;

Countries

China

Contacts

Public ContactSizhi Ai
ai5542591@13.com+86 18625960670

Outcome results

None listed

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