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A Study on the Efficacy and Mechanism of Cheek Acupuncture in Treating Primary Insomnia Based on Resting-State Magnetic Resonance Imaging

A Study on the Efficacy and Mechanism of Cheek Acupuncture in Treating Primary Insomnia Based on Resting-State Magnetic Resonance Imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002296
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Primary insomnia

Interventions

Standard acupuncture group (Group N):According to the dominant range corresponding to the standard acupoints (Selecting bilateral cervical points and upper cervical points) for acupuncture combined wi
Targeted needle Spine group (Group S):Perform acupuncture based on the corresponding target points after physical examination (taking the acupoints corresponding to the patients positive target points
Control group (Group C):Only CBT-I is accepted

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Meet the criteria for insomnia disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic criteria; 2) Persistent insomnia symptoms for more than 3 months, occurring =3 times per week; 3) Aged 18-70, right-handed; 4) Pittsburgh Sleep Quality Index (PSQI) scale score =8 points, Hamilton Depression Scale The score on the scale is =17 and the score on the Hamilton Anxiety Scale is =14; 5) I have not taken any drugs or substances that act on the nervous system in the past month, nor have I undergone any undergo acupuncture and moxibustion treatment; 6) Able to undergo buccal needle therapy and cooperate in the acquisition of magnetic resonance data; 7) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with severe comorbidities, such as coronary heart disease, malignant tumors, renal failure, etc; 2) Patients with concomitant cerebral organic diseases; 3) History of epileptic seizures 4) Co-existing with any other mental disorders (including moderate to severe anxiety and depression), personality disorders, or Individuals with abuse or dependence on psychoactive substances; 5) Those who cannot be eluted by drugs are treated with drugs or acupuncture and moxibustion; 6) Pregnant and lactating women; 7) Having contraindications for MRI examination; 8) Work as a night shift worker 9) Previous exposure to electroconvulsive therapy, transcranial magnetic stimulation, or transcranial direct current stimulation 10) Other sleep disorders exist, including sleep apnea, periodic limb movements, and sleep Abnormality, lethargy

Design outcomes

Primary

MeasureTime frame
Collect PSQI scores before treatment, at 4 weeks, 8 weeks, 12 weeks, and 20 weeks;

Secondary

MeasureTime frame
Various assessment scales, including ISI, HAMD, HAMA, ESS, FSS, and AIS, were collected before treatment, at 4 weeks, 8 weeks, 12 weeks, and 20 weeks;Before and during treatment Vital signs;The activity level of various regions in the brain at rest and within 48 hours after the 8th week of treatment fMRI data;Secondary outcomes included mental health, sleepiness and fatigue, as well as safety;

Countries

China

Contacts

Public ContactDongnan Hou

The Second Affiliated Hospital of Dalian Medical University

31922710@qq.com17709872323

Outcome results

None listed

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