Auricular Acupressure for Perimenopausal Insomnia

NCT06856421 | Not Yet Recruiting DMC

• 1 other identifier: 2024-KLS-610-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perimenopausal Insomnia

Keywords

Perimenopausal Insomnia; Auricular point

Outcome Measures

Primary Outcomes (1)

• Insomnia Severe Index

  The ISI (Insomnia Severity Index) is a widely used self-assessment tool for evaluating the severity of insomnia. Its total score categorizes the severity of insomnia into four levels: no significant clinical insomnia (0-7 points), mild insomnia (8-14 points), moderate clinical insomnia (15-21 points), and severe clinical insomnia (22-28 points). The internal consistency of the ISI is Cronbach's α = 0.76, indicating good reliability. It is highly sensitive to changes after auricular acupuncture therapy, and a decrease in the ISI score of less than 8 points indicates improvement in insomnia symptoms.

  Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks and 8 weeks after end of treatment）、

Secondary Outcomes (5)

• Pittsburgh sleep quality index

  Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks after end of treatment

• Sleep Diary

  Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks after end of treatment）

• Kupperman Index

  Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks after end of treatment）

• Menopause-specificquality of life

  Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks and 8 weeks after end of treatment）、

• Heart Rate Variability

  Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks and 8 weeks after end of treatment）、

Study Arms (2)

Ear Acupoint Pressing Group

EXPERIMENTAL

Auricular point compression

Behavioral: Auricular point compression

Sham Ear Acupoint Pressing Group

SHAM COMPARATOR

patients in this group do not perform acupoint stimulation as part of their treatment.

Behavioral: No pressure on the ear point

Interventions

Auricular point compression BEHAVIORAL

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.

Ear Acupoint Pressing Group

No pressure on the ear point BEHAVIORAL

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.

Sham Ear Acupoint Pressing Group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 45 and 55 years;
• Meetingperimenopause defined by the Staging of Reproductive Aging Workshop (STRAW);
• Patients must satisfy at least one diagnostic criterion for insomnia in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); ④ Nighttime sleep disturbances and associated perimenopausal symptoms persisting for at least 4 weeks; ⑤ No use, or stable long-term use (\>2 months) of medications for treating insomnia;
• No prior auricular acupuncture therapy, good compliance, understanding of the study protocol, and signed informed consent.

You may not qualify if:

• Non-natural menopausal transition due to premature ovarian failure, drug intake, or surgeries (e.g., oophorectomy);
• Currently pregnant or breastfeeding;
• Insomnia caused by systemic diseases (e.g., stroke, Parkinson's disease, surgery, etc.);
• Presence of insomnia symptoms before the perimenopausal period;
• Infection in the areas near selected acupoints; ⑦ History of alcohol or substance abuse/addiction；
• Co-existing mental or psychological disorders (e.g., depression, generalized anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.) or suicidal tendencies, in addition to insomnia; ⑨ Receipt of auricular acupuncture therapy within the past 3 months; ⑩ Participation in other clinical trials in the past 3 months;
• Any known chronic pain disorders that could affect sleep.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• Howest: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location

Central Study Contacts

Honggen Du, Doctor

CONTACT

+8613958058996; 19963024@zcmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To maintain blinding integrity throughout the trial duration, all participants, clinical outcome assessors, and data analysts will remain blinded to treatment allocation. In instances requiring concurrent treatment sessions, patients will undergo staggered screening processes and be assigned to separate isolated treatment rooms, thereby eliminating potential inter-participant communication that could inadvertently compromise blinding efficacy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Perimenopausal insomnia patients

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2025-3-1

Locations

CN (1)