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Observation of the efficacy of acupuncture combined with acupoint injection in the treatment of sleep disorders secondary to subjective tinnitus

Observation of the efficacy of acupuncture combined with acupoint injection in the treatment of sleep disorders secondary to subjective tinnitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000597
Enrollment
Unknown
Registered
2026-03-18
Start date
2025-07-28
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

tinnitus

Interventions

Treatment group:Acupuncture and acupoint injection
Control group:Comfort acupuncture comfort acupuncture point injection

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 65 years old (including 18 and 65 years old) gender is not limited; (2) Meet the diagnostic criteria of modern medicine for tinnitus; (3) Meet the diagnostic criteria of traditional Chinese medicine for tinnitus and insomnia; (4) The Pittsburgh sleep quality index = 7 points and the sleep quality decreased only after the symptoms of tinnitus; (5) Patients have a full understanding of this study and can persist in completing the treatment course and regular follow-up visits (6) Volunteer to participate in the trial sign the informed consent form and cooperate with the treatment.

Exclusion criteria

Exclusion criteria: (1) Secondary tinnitus caused by external ear lesions (such as external auditory canal foreign body cerumenal embolism etc.) or secondary tinnitus caused by middle ear inner ear (such as Meniere's disease otitis media etc.) central lesions etc. and tinnitus outside the auditory system (such as vascular pulsatile tinnitus myoclonic tinnitus etc.); (2) Insomnia caused by serious primary diseases such as nervous system cardiovascular and cerebrovascular diseases and mental illness; (3) Patients with skin diseases and coagulation dysfunction at acupuncture and acupoint injection sites; (4) Those who are allergic to methylcobalamin (including injection and oral tablets) and alprazolam; (5) Those with severe respiratory insufficiency; Severe liver and kidney insufficiency; Acute angle-closure glaucoma; Pregnant and lactating women; (6) Patients with cognitive dysfunction who cannot understand and fill in the evaluation scale by themselves; (7) Have taken sedatives and other drugs that may affect the test results in the first month before treatment; (8) Patients with insomnia due to habitual drinking of strong tea coffee and other life factors; (9) Patients who self-reported insomnia symptoms but had a Pittsburgh sleep quality index of <7; (10) Patients who are very afraid of acupuncture and other patients with poor compliance due to psychological disorders and other reasons.

Design outcomes

Primary

MeasureTime frame
Tinnitus Evaluation Questionnaire;Pittsburgh sleep quality index;

Secondary

MeasureTime frame
Tinnitus Handicap Inventory;TCM syndrome score scale;

Countries

China

Contacts

Public Contactliziping

Guangdong Provincial Hospital of Traditional Chinese Medicine

1483589468@qq.com15768886944

Outcome results

None listed

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