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Investigate the Clinical Study of 'Tongdu Tiaoshen' Acupuncture in the Intervention of Hypertension with Insomnia Based on PPSG

Investigate the Clinical Study of 'Tongdu Tiaoshen' Acupuncture in the Intervention of Hypertension with Insomnia Based on PPSG

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005911
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Hypertension with insomnia

Interventions

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. No gender restriction, ages 18-70. 2. Meeting the ICSD-3 diagnostic criteria for insomnia; 3. 8=ISI score=22 4. Patients who meet the diagnostic criteria of essential hypertension, and the cardiovascular risk stratification is low to medium risk, the blood pressure control is relatively stable, and the types of hypertension drugs taken are CCB+ACEI/ARB, but no more than two types; 5. Voluntarily participate in this trial and sign the informed consent form, and the process of obtaining the informed consent form should comply with GCP regulations.

Exclusion criteria

Exclusion criteria: 1. Patients with serious physical diseases; 2. HAMA score=2 or HAMD score=18 3. Caffeinealcohol or psychotropic substances dependence; 4. Other types of sleep disorders such as sleep apnea and restless legs syndrome; 5. Night shift workers 6. Stop insomnia-related interventions (including traditional Chinese medicine, acupuncture, massage, and western medicine)=2 weeks; 7. Change of antihypertensive plan within the last 1 month; 8. Pregnant and lactating women; 9. At the same time participate in other research groups.

Design outcomes

Primary

MeasureTime frame
Heart Rate Variability;Sleep parameters of Portable Polysomnography;

Secondary

MeasureTime frame
home blood pressure monitoring;Insomnia Severity Index scale;pittsburgh sleep quality index scale;

Countries

China

Contacts

Public ContactWang Xiaoqiu
1003937028@qq.com17805008180

Outcome results

None listed

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