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To evaluate the efficacy and safety of multimodal treatment for intractable insomnia

To evaluate the efficacy and safety of multimodal treatment for intractable insomnia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076511
Enrollment
Unknown
Registered
2023-10-10
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Intractable insomnia

Interventions

Cognitive behavioral therapy alone group (group C):CBTI+Transcranial Magnetic Stimulation
Multimodal therapy combined group (group M):CBT, stellate ganglion block, anesthesia sleep balance, transcranial magnetic stimulation, and other multimodal combined therapies

Sponsors

The First Affiliated Hospital of Henan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) meet the above-mentioned diagnostic criteria of western medicine and traditional Chinese medicine for insomnia; (2) The age of onset was between 18 and 65 years old, both male and female; (3) the course of disease was 6 months or more; (4) Pittsburgh Sleep Quality Index (PSQI) score was more than 7 points, Hamilton Depression Scale score was less than 24 points, and Hamilton Anxiety Scale score was less than 21 points. (5) Patients had never taken relevant sedative and tranquilizing drugs, or had no effect after taking them and the drug withdrawal time was more than 1 month; (6) able to read, self-recognize and complete various rating scales independently; (7) can cooperate and adhere to the treatment of this regimen, complete all courses of treatment, and have good compliance.

Exclusion criteria

Exclusion criteria: (1) Patients with insomnia caused by other diseases, such as mental diseases and organic diseases, cannot be excluded; (2) special population, such as pregnant and lactating women; (3) complicated with serious heart, brain, liver, kidney and other organs lesions; (4) patients receiving other treatments at the same time, which may affect the results of this study; (5) patients with drug allergy; (6) patients with contraindications to nerve block.

Design outcomes

Primary

MeasureTime frame
The total score of Pittsburgh Sleep Quality Index (PSQI) scale was recorded;

Secondary

MeasureTime frame
The six-item factor scores of the PSQI scale;Hamilton Depression Scale (HAMD) score;Hamilton Anxiety Scale (HAMA);Huawei watch sleep parameters;Activity of sleep related central neurotransmitters;

Countries

China

Contacts

Public ContactMao Shanshan

The First Affiliated Hospital of Henan University

980160045@qq.com+86 184 3632 6264

Outcome results

None listed

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