NCT06856421

Auricular Acupressure for Perimenopausal Insomnia

Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to determine whether auricular Acupressure therapy can improve symptomatic insomnia in perimenopausal women. Can ear acupressure therapy significantly improve sleep quality in perimenopausal women with insomnia? What medical issues or adverse reactions might participants experience during the treatment? Researchers will compare ear acupressure therapy with traditional treatments in a control group to assess its effectiveness and safety. Participants will: Receive auricular acupressure on Monday and Thursday, applying pressure for 3 consecutive days each week. This process will continue for 4 weeks, totaling 8 sessions. Record assessment points as follows: Baseline (2 weeks before treatment to Week 0), mid-treatment (2 weeks after treatment begins), end of treatment (4 weeks after treatment begins), and follow-up (4 weeks after treatment ends) for primary and secondary outcome indicators. Eight weeks after treatment concludes, only the primary outcome indicator (Insomnia Severity Index) will be recorded. This trial seeks to evaluate the potential benefits and safety profile of auricular acupressure therapy for managing insomnia in perimenopausal women.

Detailed description

This is a multicenter, randomized, controlled clinical trial. Perimenopausal insomnia patients will be randomly assigned to the ear acupoint pressing group or the sham ear acupoint pressing group in a 1:1 ratio. 2.2 Randomization and Blinding Sequence Generation * Allocation ratio: 1:1 randomization between groups * Randomized groups: Genuine auricular acupressure group vs. Sham auricular acupressure group * Randomization tool: SAS software version 9.3 (SAS Institute Inc.) * Sequence generation: Performed by an independent statistician with no involvement in trial execution or statistical analysis Allocation Concealment Mechanism * Sequence storage: Secured in a dedicated randomization sequence management system inaccessible to study personnel * Implementation: Centralized web-based randomization system assigns participants with equal probability after baseline assessments * Coordination: Clinical research coordinators initiate randomization requests Blinding Procedures * Blinded parties: Participants, outcome assessors, and statisticians remain blinded to group assignments * Treatment isolation: Concurrent treatments for ≥2 participants conducted in separate rooms to prevent cross-communication * Data confidentiality: Intervention details withheld until final statistical analysis completion * Blind maintenance: Comprehensive measures implemented to preserve blinding integrity * Emergency unblinding: Permitted only for acute medical emergencies requiring urgent clinical management Unblinded participants discontinued from efficacy analysis but retained in safety datasets Alternative therapeutic options provided to affected participants • Ethical disclosure: Participants informed about two distinct intervention arms while maintaining blinding integrity Training: Acupuncture doctors supervising medical staff at various centers will provide training on techniques, ensuring uniform implementation across all sites. 2.3 Blinding Assessment for Assessors and Participants Data Collection * Administer post-treatment questionnaires to participants and assessors to document perceived group assignments Blinding Indices Calculation * James Blinding Index (JBI): Range: 0 (complete unblinding) to 1 (perfect blinding) Blinding failure threshold: Two-sided confidence interval upper limit \<0.5 • Bang Blinding Index (BBI): Range: -1 (ideal blinding) to 1 (complete unblinding) Blinding failure threshold: One-sided confidence interval excludes 0 Statistical Implementation * Analysis performed using R statistical software (version ≥4.2.0) for index calculations and confidence interval estimation Interpretation \& Reporting * Investigate root causes if indices suggest compromised blinding * Full documentation of methodology, results, and conclusions in clinical study reports Emergency Unblinding Protocol * Strict adherence to predefined Standard Operating Procedures (SOPs) for urgent unmasking scenarios Blinding Quality Assurance * Regular monitoring/auditing of blinding integrity * Preventive measures against accidental unmasking Evaluation Indicators: Primary Outcome: Insomnia Severity Index (ISI) Secondary Outcomes: Pittsburgh Sleep Quality Index (PSQI), Sleep Diary, Kupperman Index (KI), Menopause-Specific Quality of Life (MENQOL), Heart Rate Variability (HRV) Emergency Medication: Eszopiclone (Pharmaceutical Co., Ltd, China) will be used as emergency medication under the guidance of a psychiatric expert. The usage frequency, dosage, number of patients, and administration details during the trial will be recorded for subsequent analysis. Follow-Up: Follow-up assessments will take place at 4 weeks post-treatment for secondary outcomes and at 8 weeks post-treatment for ISI (primary outcome).

Conditions

• Perimenopausal Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Auricular point compression	Acupuncture Points: Endocrine, Sympathetic, Shenmen, Heart Procedure Instructions: Disinfect the areas with 75% alcohol as per standard precautions. Treatments use only ear patches without Vaccaria seeds applied to these specific acupuncture points. Treatment sessions occur every Monday and Thursday. On Mondays, left ears are patched for three continuous days. Then on Thursdays, qualified medical personnel will remove the patches from the left ear and apply new patches to the right ear for four consecutive days. Any replacements must be performed at the hospital by qualified staff; patients should not attempt to do this themselves. This procedure is repeated weekly over a span of four weeks, resulting in eight total applications. Importantly, patients in this group do not perform acupoint stimulation as part of their treatment.
BEHAVIORAL	No pressure on the ear point	Acupuncture Points: Endocrine, Sympathetic, Shenmen, Heart Procedure Instructions: Disinfect the areas with 75% alcohol as per standard precautions. Treatments use only ear patches without Vaccaria seeds applied to these specific acupuncture points. Treatment sessions occur every Monday and Thursday. On Mondays, left ears are patched for three continuous days. Then on Thursdays, qualified medical personnel will remove the patches from the left ear and apply new patches to the right ear for four consecutive days. Any replacements must be performed at the hospital by qualified staff; patients should not attempt to do this themselves. This procedure is repeated weekly over a span of four weeks, resulting in eight total applications. Importantly, patients in this group do not perform acupoint stimulation as part of their treatment.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-03-04
• Last updated: 2025-04-30

Locations

1 site across 1 country: China