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Auricular acupoint therapy for primary insomnia: a multicenter randomized controlled trial

Acupuncture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006725
Enrollment
Unknown
Registered
2022-10-31
Start date
2022-11-03
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

primary insomnia

Interventions

Treatment Group:Auricular Acupoint Bloodletting plus Auricular Acupressure
Control Group:Consolatory Auricular Acupoint Bloodletting plus Auricular Acupressure

Sponsors

College of Acupuncture Moxibustion and Massage, Hebei University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Meets the diagnostic criteria for the DSM-5. ?Aged 18-65 years, regardless of gender; ?The Pittsburg Sleep Quality Index(PSQI) total score was more than 7 points and the Insomnia Severity Index (ISI) score was more than 8 points but less than 21 points. ?No sedative-hypnotic drug therapy, psychotherapy, or auricular therapy were received within 2 weeks before enrollment; ?The patients were informed of the study and signed the informed consent, as well as they were willing to accept follow-up after the end of the study.

Exclusion criteria

Exclusion criteria: ?Patients with a history of psychiatric or bipolar disorder and those with the following major sleep disorders: sleep apnea (apnea/hypopnea index > 15), restless leg syndrome, periodic limb movement during sleep (PLMS with arousal > 15 per hour), circadian rhythm disorder, and parasomnias; ?The SDS(Self-Rating Anxiety Scale) score was greater than 72 (including 72), and the SAS(Self-Rating Anxiety Scale) score was greater than 69 (including 69) ?Pregnant or lactating women; ?Ear redness, ulceration, scar and allergic to tape at the time of any therapy session; ?Patients with hemorrhagic diseases, coagulation disorders, hyperglycemia and anemia; ?The patient did not want to take the Actigraphy ?Other clinical investigators are planned to be included or have been included.

Design outcomes

Primary

MeasureTime frame
the response rate at week 4 after randomization;

Secondary

MeasureTime frame
sleep rate;Pittsburg Sleep Quality Index score;Self-Rating Anxiety Scale score;Self-Rating Anxiety Scale score;World Health Organization Quality of Life BREF score;Insomnia Severity Index score;

Countries

China

Contacts

Public ContactShe Yanfen
sheyanfen@163.com15833955088

Outcome results

None listed

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