Perimenopausal InsomniaNCT07708324
Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia
A study testing Auricular Acupressure in people with Perimenopausal Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
Trial summary
Perimenopausal insomnia is a condition where women frequently experience poor sleep around the time of perimenopause due to perimenopausal syndrome. It mostly affects women aged 40 to 55. Compared to primary insomnia, this type has the highest incidence and comes with complex physiological and hormonal changes. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Perimenopausal Insomnia
- What is being tested?
- Auricular Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, aged 40-55 years.
- Meets the STRAW criteria for perimenopause.
- Meets DSM-5 diagnostic criteria for insomnia disorder.
- Insomnia symptoms have persisted for at least 4 weeks.
- Has not used insomnia medication or has received a stable dose for at least 2 months.
- Has not previously received auricular acupressure.
- Able to comply with study procedures.
- Provides written informed consent.
Who cannot join
- Pregnancy or lactation.
- Premature ovarian insufficiency.
- Surgical menopause.
- Insomnia secondary to neurological disease.
- Major psychiatric disorders.
- Alcohol or substance abuse.
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- Skin infection at auricular sites.
- Participation in another clinical trial within the previous 3 months.
- Chronic pain disorders affecting sleep.
About this study
Official title: Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Trial
Perimenopausal insomnia is a condition where women frequently experience poor sleep around the time of perimenopause due to perimenopausal syndrome. It mostly affects women aged 40 to 55. Compared to primary insomnia, this type has the highest incidence and comes with complex physiological and hormonal changes. Insomnia during this phase is more than just a sleep problem; it is often accompanied by symptoms like hot flashes and night sweats, which have a broad negative impact on women's physical and mental well-being. Therefore, finding effective treatment strategies is especially important.
Currently, the main treatments for perimenopausal insomnia include cognitive therapy, hormone replacement therapy (HRT), and sedative-hypnotic drugs. As first-line options, cognitive therapy and HRT are widely recognized for their positive effects on improving sleep. However, long-term use of these medications can lead to dependency and increase the risk of endometrial cancer, breast cancer, stroke, and coronary heart disease. As a result, finding a safe and effective non-drug alternative is highly meaningful. At present, there is still a lack of high-quality research evidence to fully confirm the exact efficacy of auricular acupressure for perimenopausal insomnia.
- Conditions
- Perimenopausal Insomnia
- Being tested
- Auricular Acupressure, sham Auricular Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupressureOther
Auricular acupressure using adhesive plasters containing Vaccaria seeds.
sham Auricular AcupressureOther
Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Other | Participants will receive auricular acupressure using adhesive auricular plasters containing Vaccaria seeds applied to the endocrine, sympathetic, Shenmen, and heart auricular acupoints. Participants will be instructed to press each seed for 30 seconds, three times daily, for 4 weeks. Adhesive plasters will be replaced twice weekly. Receives: Other: Auricular Acupressure |
| Control Group | Sham comparator | Participants will receive sham auricular plasters applied to the same auricular locations without Vaccaria seeds and will not be instructed to apply pressure. Plasters will be replaced on the same schedule as the experimental group. Receives: Other: sham Auricular Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a validated 7-item questionnaire with total scores ranging from 0 to 28. Higher scores indicate more severe insomnia.
Measured: Baseline, Week 2 (±3 days), Week 4 (±3 days), Week 8 (±3 days), Week 12 (±3 days); or at early withdrawal if applicable.
Secondary outcomes (5)
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire assessing sleep quality over the previous month. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable
Sleep Diary
Participants will complete a standardized daily sleep diary to record bedtime, sleep onset latency, number of nocturnal awakenings, wake after sleep onset, wake-up time, total sleep time, and subjective sleep quality. Diary data will be summarized over the predefined assessment period for analysis.
Measured: Daily throughout the study; summarized at Baseline, Week 2 (±3 days), Week 4 (±3 days), and Week 8 (±3 days).
Kupperman Index
The Kupperman Index is a validated questionnaire used to assess the severity of menopausal symptoms, including hot flashes, sweating, insomnia, mood changes, fatigue, and other climacteric symptoms. Higher total scores indicate greater symptom severity.
Measured: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
Menopause-Specific Quality of Life Questionnaire
The Menopause-Specific Quality of Life (MENQOL) questionnaire is a validated self-reported instrument that assesses menopause-related quality of life across vasomotor, psychosocial, physical, and sexual domains. Scores will be calculated according to the validated scoring manual used in this study. Higher scores indicate poorer menopause-specific quality of life.
Measured: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
Heart Rate Variability
Heart rate variability (HRV) will be assessed using standardized electrocardiographic recordings as an objective measure of autonomic nervous system function. Time-domain and frequency-domain HRV parameters will be analyzed according to the predefined study protocol.
Measured: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Shao, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708324
- Sponsor's protocol ID
- 2026-KLS-213-02
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07708324
- Acronym / sponsor ID
- 2026-KLS-213-02
- Conditions
- Perimenopausal Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perimenopausal insomnia is a condition where women frequently experience poor sleep around the time of perimenopause due to perimenopausal syndrome. It mostly affects women aged 40 to 55. Compared to primary insomnia, this type has the highest incidence and comes with complex physiological and hormonal changes. Insomnia during this phase is more than just a sleep problem; it is often accompanied by symptoms like hot flashes and night sweats, which have a broad negative impact on women's physical and mental well-being. Therefore, finding effective treatment strategies is especially important.
Currently, the main treatments for perimenopausal insomnia include cognitive therapy, hormone replacement therapy (HRT), and sedative-hypnotic drugs. As first-line options, cognitive therapy and HRT are widely recognized for their positive effects on improving sleep. However, long-term use of these medications can lead to dependency and increase the risk of endometrial cancer, breast cancer, stroke, and coronary heart disease. As a result, finding a safe and effective non-drug alternative is highly meaningful. At present, there is still a lack of high-quality research evidence to fully confirm the exact efficacy of auricular acupressure for perimenopausal insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Other | Other: Auricular AcupressureParticipants will receive auricular acupressure using adhesive auricular plasters containing Vaccaria seeds applied to the endocrine, sympathetic, Shenmen, and heart auricular acupoints. Participants will be instructed to press each seed for 30 seconds, three times daily, for 4 weeks. Adhesive plasters will be replaced twice weekly. |
| Control Group | Sham comparator | Other: sham Auricular AcupressureParticipants will receive sham auricular plasters applied to the same auricular locations without Vaccaria seeds and will not be instructed to apply pressure. Plasters will be replaced on the same schedule as the experimental group. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female, aged 40-55 years.
- Meets the STRAW criteria for perimenopause.
- Meets DSM-5 diagnostic criteria for insomnia disorder.
- Insomnia symptoms have persisted for at least 4 weeks.
- Has not used insomnia medication or has received a stable dose for at least 2 months.
Key exclusion criteria (9 listed)
- Pregnancy or lactation.
- Premature ovarian insufficiency.
- Surgical menopause.
- Insomnia secondary to neurological disease.
- Major psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular AcupressureAuricular acupressure using adhesive plasters containing Vaccaria seeds. | Other | Treatment Group |
| sham Auricular AcupressureSham auricular adhesive plasters without Vaccaria seeds or pressure stimulation. | Other | Control Group |
Primary outcome
Insomnia Severity Index
Time frame: Baseline, Week 2 (±3 days), Week 4 (±3 days), Week 8 (±3 days), Week 12 (±3 days); or at early withdrawal if applicable.
The Insomnia Severity Index (ISI) is a validated 7-item questionnaire with total scores ranging from 0 to 28. Higher scores indicate more severe insomnia.
5 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable
Sleep Diary
Time frame: Daily throughout the study; summarized at Baseline, Week 2 (±3 days), Week 4 (±3 days), and Week 8 (±3 days).
Kupperman Index
Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
Menopause-Specific Quality of Life Questionnaire
Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
Heart Rate Variability
Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure in people with Perimenopausal Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Baseline, Week 2 (±3 days), Week 4 (±3 days), Week 8 (±3 days), Week 12 (±3 days); or at early withdrawal if applicable.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.