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Clinical application research plan of biofeedback physical regulation of blood pressure and sleep disorders

Clinical application research plan of biofeedback physical regulation of blood pressure and sleep disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053852
Enrollment
Unknown
Registered
2021-12-01
Start date
2022-03-01
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

Hypertension

Interventions

Control group 1:Antihypertensive drugs
Experimental group 1:Antihypertension+biofeedback electrical stimulation
Control group 2:Antihypertension+anxiolytics
Experimental group 2:Antihypertension+anxiolytics+biofeedback electrical stimulation

Sponsors

Chinese PLA General Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for hypertension in ''Chinese Expert Consensus on the Diagnosis and Treatment of Hypertension (2014 Edition)'', the blood pressure continues to rise or the blood pressure is measured 3 times in a resting state on different days, and the systolic blood pressure is >=140 mm Hg (1mm Hg = 0.133 kPa) and/or diastolic blood pressure >= 90 mm Hg, or a diagnosed history of hypertension. 2.(1) Sleep disorders: The sleep quality of the patients was evaluated by the Insomnia Severity Index Scale, of which the total score of 8 points and above was considered to have sleep disorders; (2) Anxiety state: GAD-7 scale was used to evaluate the patient's psychological state, of which there was anxiety state with a total score of 9 or more; (3) Depressive state and somatic symptoms: The PHQ-9 scale was used to evaluate whether the patients had depression, and those with a total score of 9 or more were defined as having a depressive state; The PHQ-15 scale was used to evaluate whether the patients had physical problems, and those with a total score of 9 or more were defined as having physical symptoms.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. In the acute phase of the disease, hemodynamic instability, such as rapidly progressive hypertension, acute myocardial infarction, acute heart failure, acute pancreatitis, etc.; 3. Poor control of chronic obstructive pulmonary disease (respiratory failure state); 4. Patients with renal insufficiency (CKD stage 4); 5. Patients with hepatic insufficiency; 6. Patients with diabetic ketoacidosis; 7. Patients with type 1 diabetes; 8. Patients with advanced malignant tumor (survival period < 1 year); 9. Suffering from skin diseases or allergies, unable to contact materials such as patches for a long time; 10. Suffering from mental disorders (diagnosed by psychiatry specialists); 11. Pregnant patients; 12. Any poorly controlled systemic disease; 13. The patient refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
24-hour ambulatory blood pressure;blood pressure variability;

Countries

China

Contacts

Public ContactXu Yong
13701141929@163.com+86 13701141929

Outcome results

None listed

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