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Clinical research on acupuncture treatment of chronic insomnia by polysomnography combined with real-time EEG monitoring.

Clinical research on acupuncture treatment of chronic insomnia by polysomnography combined with real-time EEG monitoring.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037973
Enrollment
Unknown
Registered
2020-09-08
Start date
2020-09-15
Completion date
Unknown
Last updated
2020-11-16

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

Conditions

Insomnia

Interventions

Acupuncture group:Acupuncture
Sham acupuncture group:Sham acupuncture
Healthy control group:Nil

Sponsors

Jiangsu Privince Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. The sex is female; 2. The age was 35-45 years old; The diagnostic criteria were ICs3; 4. PSQI score: 7-14; 5. The course of disease was 3 months to 5 years; 6. Have high education level (college degree or above); 7. Urine pregnancy test was negative; 8. No communication and cognitive impairment; 9. Sign informed consent. The inclusion criteria of healthy volunteers were as follows: (1) The total sleep time was more than 7 hours; (2) The latency of falling asleep was less than 30 min; (3) The symptoms such as night awakening and early awakening were less than 3 times / week; (4) Regular work and rest, no shift; (5) No complaints about sleep quality and time + 1, 2, 6, 7, 8, 9.

Exclusion criteria

Exclusion criteria: 1. The patients with sleep disorder caused by depression, anxiety, schizophrenia or other serious mental diseases, HAMA score > 14 points and / or HAMD score > 17 points; 2. Patients diagnosed with other sleep disorders, or any other sleep disorders found on the PSG at baseline, such as obstructive sleep apnea, rapid eye movement (REM) sleep disorders, or restless legs syndrome; 3. Patients with serious diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, or malignant tumor; 4. Patients with history of thyroid dysfunction, such as hyperthyroidism and hypothyroidism; 5. In patients with abnormal estrogen secretion, ovariectomy or hysterectomy is the latter; 6. Pregnant women and lactating women who are not suitable for acupuncture treatment; 7. Patients with a history of sleeping drugs in recent 3 months, or taking histamine, glucocorticoid, ephedrine, theophylline and other drugs that affect sleep; 8. Patients who have received acupuncture treatment within 1 month and / or behavioral cognitive therapy within 2 weeks; 9. Patients with alcohol and / or other drug abuse or dependence; 10. Patients who cannot cooperate with EEG monitoring.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Polysomnography;RT-EEG;

Countries

China

Contacts

Public ContactWu Wenzhong

Jiangsu Privince Hospital of Chinese Medicine

Maerta_zhong@hotmail.com+86 13851603326

Outcome results

None listed

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