Clinical trial NCT06856421: Auricular Acupressure for Perimenopausal Insomnia
Official title: Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perimenopausal Insomnia
Keywords: Perimenopausal Insomnia
Auricular point
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Howest
First posted: 2025-03-04
Enrollment: 160
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Perimenopausal insomnia patients
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Does not meet inclusion criteria;

  * 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.

Primary outcomes:
measure: Insomnia Severe Index
timeFrame: 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:
measure: Pittsburgh sleep quality index
timeFrame: 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
measure: Sleep Diary
timeFrame: 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）
measure: Kupperman Index
timeFrame: 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）
measure: Menopause-specificquality of life
timeFrame: 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）、
measure: Heart Rate Variability
timeFrame: 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）、
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References: