Chronic Insomnia During Perimenopause and MenopauseNCT07229976
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
A study testing thumbtack needle in people with Chronic Insomnia During Perimenopause and Menopause, run by Huazhong University of Science and Technology at 8 sites in China.
Trial summary
A multicenter, randomized, controlled, blinded clinical trial was conducted to evaluate the effects of thumbtack needle on sleep in patients with chronic insomnia during perimenopause and menopause. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Chronic Insomnia During Perimenopause and Menopause
- What is being tested?
- thumbtack needle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 8 sitesChina
- Study dates
- 20 Mar 2026to 30 Dec 2029
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 40 to 65 who meet the diagnostic criteria for perimenopause and menopause mentioned above;
- Evaluate ISI score ≥ 12 points through a scale;
- Meets the diagnostic criteria for chronic insomnia mentioned above, i.e. ICSD-3 meets both criteria A to F;
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Patients who meet any of the following conditions will not be included;
- Use hormone replacement therapy, anti anxiety drugs, antidepressants, or medications to improve insomnia within one month;
- Individuals with a history of diagnosed sleep disorders before menopause;
- Combined with other sleep disorders such as obstructive sleep apnea, restless leg syndrome, etc;
- Patients with malignant tumors, especially estrogen dependent tumors (such as breast cancer and endometrial cancer);
- Recent (within 6 months) history of myocardial infarction, stroke, venous thrombosis, etc;
Show all 14Show fewer
- Patients with mental illnesses, such as severe depression and uncontrolled schizophrenia;
- Serious disorder of endocrine system, such as uncontrolled hyperthyroidism, diabetes ketoacidosis, etc
- Patients with coagulation disorders, such as hemophilia, long-term use of anticoagulants (warfarin, aspirin, etc.), etc;
- Long term alcohol consumption history (more than 5 years, daily alcohol consumption exceeding 12 taels, not quitting drinking);
- Engaged in night shift work (>3 times a week);
- Individuals with infections, ulcers, burns, rashes, or scars at acupoints;
- Previously received acupuncture treatment;
- I do not agree to sign the informed consent form for this study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Aksu Prefecture Maternal and Child Health Hospital
Aksu, XUAR, 843099
Long Long Fan, +86 18935844102, fll8301@163.com
- Recruiting
Chibi Maternal and Child Health Hospital
Chibi, Hubei, 437300
Mei Bao Wang, +86 13797220703, 851527501@qq.com
- Recruiting
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, 430000
Hongying Xu, +86 18972363268, 110810237@qq.com
- Recruiting
Qianjiang Central Hospital
Qianjiang, Hubei, 433100
Yun Zhou, +86 15927626992, 247961335@qq.com
- Recruiting
Wuhan Children's Hospital
Wuhan, Hubei, 430015
Shan Li Zhou, +86 18086029059, sophiachou0913@126.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Qiao Wu, +86 13487095852, 787459236@qq.com
- Recruiting
Rehabilitation Center, Wuhan Puren Hospital
Wuhan, Hubei, 430080
Qing Wang, +86 15002738336, qingpin6686@126.com
- Recruiting
Xiaogan Maternal and Child Health Care Hospital
Wuhan, Hubei, 432000
Lin Dr. Nie, +86 13669020358, 7725553@qq.com
About this study
Official title: Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women: A Multicenter Randomized Controlled Trial
A multicenter, randomized, controlled, blinded clinical trial was conducted to evaluate the effects of thumbtack needle on sleep in patients with chronic insomnia during perimenopause and menopause. Randomly divided into a treatment group and a control group using the central area method, with 99 patients in each group. The treatment group received thumbtack needle treatment, while the control group received placebo thumbtack needle treatment. The treatment course for both groups was 4 weeks.
- Being tested
- thumbtack needle, placebo thumbtack needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thumbtack needleOther
The treatment acupoints include bilateral Anmian Acupoint, bilateral Taichong acupoints, bilateral Neiguan acupoints, bilateral Sanyinjiao (SP6), and bilateral Zusanli (ST36) and Danzhong acupoints, a total of 11 acupoints. After 3 days of thumbtack needle retention, the patient went to the hospital where the doctor removed the thumbtack needle, disinfected the local skin, and received the next needle treatment. The patient received treatment twice a week (6 days) and rested for 1 day before continuing with the next treatment.
placebo thumbtack needleOther
The placebo thumbtack needle group selected acupoints that were the same as the thumbtack needle group. Bilateral sleeping acupoints, bilateral Taichong acupoints, bilateral Neiguan acupoints, bilateral Sanyinjiao (SP6), bilateral Zusanli (ST36), and Danzhong acupoints are all treated with comforting acupressure.where the doctor removed the placebo thumbtack needle, disinfected the local skin, and received the next placebo thumbtack needle needle. The patient received treatment twice a week (6 days) and rested for 1 day before continuing with the next treatment.
| Study group | Role | What they receive |
|---|---|---|
| thumbtack needle group | Experimental | The subject received thumbtack needle Receives: Other: thumbtack needle |
| Placebo thumbtack needle group | Other | The subject received placebo thumbtack needle Receives: Other: placebo thumbtack needle |
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 self-assessment tool used to evaluate the severity of insomnia. The ISI scale consists of 7 items, each rated on a scale of 0-4, with a total score range of 0-28 points. Evaluate the difference in scores between the Insomnia Severity Index (ISI) scale at the end of week 4 and baseline ISI scores.
Measured: 4 weeks
Secondary outcomes (23)
Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PSQI) is a widely used sleep quality assessment tool internationally. Evaluate the difference between the PSQI score at the end of week 4 and the baseline PSQI score.
Measured: 4 weeks
Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) is a self-assessment tool used to evaluate an individual's level of daytime sleepiness. Evaluate the difference between the ESS score at the end of week 4 and the baseline ESS score.
Measured: 4 weeks
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is currently one of the most commonly used scales for assessing fatigue symptoms in clinical practice. Assess the difference between FSS score at the end of week 4 and baseline FSS score .
Measured: 4 weeks
Zung Self Rating Anxiety Scale
The Zung Self Rating Anxiety Scale (SAS) is used to assess the severity of an individual's anxiety symptoms over the past week. Evaluate the difference between the SAS score at the end of week 4 and the baseline SAS score.
Measured: 4 weeks
Zung Self Rating Depression Scale
The Zung Self Rating Depression Scale (SDS) is currently one of the most widely used self-assessment scales for depression. Evaluate the difference between SDS score at the end of week 4 and baseline SDS score.
Measured: 4 weeks
Sleep efficiency
Sleep efficiency refers to the ratio of actual sleep time to bed rest time. Evaluate the difference between sleep efficiency at the end of week 2 and week 4 and baseline sleep efficiency.
Measured: 2 weeks，4 weeks
wake-up time after sleep onset
Assess the difference between the wake-up time after sleep onset at the end of week 2 and week 4, and the wake-up time after baseline sleep onset.
Measured: 2 weeks, 4 weeks
the number of awakenings per night
Evaluate the difference between the number of awakenings per night at the end of week 2 and week 4 compared to the baseline number of awakenings per night.
Measured: 2 weeks, 4 weeks
The latent period of sleep onset
The latent period of sleep onset refers to the time it takes from getting ready to sleep to actually entering a state of sleep. Evaluate the difference between the sleep onset latency at the end of week 2 and week 4 and the baseline sleep onset latency.
Measured: 2 weeks, 4 weeks
Total sleep time
Total sleep time refers to the total duration of continuous or intermittent sleep that an individual experiences within a certain period of time (usually 24 hours). Evaluate the difference between the total sleep time at the end of week 2 and week 4 and the baseline total sleep time.
Measured: 2 weeks, 4 weeks
the average wake-up time
Evaluate the difference between the average wake-up time at the end of week 2 and week 4 and the baseline average wake-up time.
Measured: 2 weeks, 4weeks
Corticotropin-Releasing Hormone
Corticotropin Releasing Hormone (CRH) is a peptide hormone secreted by the hypothalamus. Evaluate the difference in serum CRH concentration between the thumbtack needle group and the placebo thumbtack needle group at the end of week 4.
Measured: 4 weeks
Norepinephrine
Norepinephrine is both a neurotransmitter and a hormone. Evaluate the difference in serum Norepinephrine concentration between the thumbtack needle group and the placebo thumbtack needle group at the end of week 4.
Measured: 4 weeks
Adrenaline
Adrenaline is a hormone and neurotransmitter secreted by the adrenal medulla. Evaluate the difference in serum Adrenaline concentration between the thumbtack needle group and the placebo thumbtack needle group at the end of week 4.
Measured: 4 weeks
5-hydroxytryptamine
5-hydroxytryptamine (5-HT), also known as serotonin, is an important monoamine neurotransmitter that plays a crucial role in the physiological and psychological functions of the human body. Evaluate the difference in serum 5-HT concentration between the thumbtack needle group and the placebo thumbtack needle group at the end of week 4.
Measured: 4 weeks
Gamma aminobutyric acid
Gamma aminobutyric acid (GABA) is a non protein amino acid widely present in the human body, animals, and plants, and is also an important inhibitory neurotransmitter in the central nervous system. Evaluate the difference in serum GABA concentration between the thumbtack needle group and the placebo thumbtack needle group at the end of week 4.
Measured: 4 weeks
Dopamine
Dopamine is an important neurotransmitter that has a wide range of effects on human physiological and psychological functions. Evaluate the difference in serum Dopamine concentration between the thumbtack needle group and the placebo thumbtack needle group at the end of week 4.
Measured: 4 weeks
Melatonin
Melatonin is an endogenous hormone secreted by the pineal gland of the human brain. Evaluate the difference in serum melatonin concentration between the thumbtack needle group and the placebo thumbtack needle group at the end of week 4.
Measured: 4 weeks
β - endorphin
Evaluate the difference in serum β - endorphin concentration between the placebo group and the placebo group at the end of week 4.
Measured: 4 weeks
insomnia remission rate
The proportion of patients who no longer meet the diagnosis of insomnia after treatment among those receiving insomnia treatment. The diagnosis of insomnia refers to the International Classification of Sleep Disorders, ICSD-3
Measured: 4 weeks
Insomnia Treatment Response Rate
The proportion of patients receiving insomnia treatment whose Insomnia Severity Index score decreased by 8 or more points after treatment
Measured: 4 weeks
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a self-assessment tool used to evaluate the severity of insomnia. The ISI scale consists of 7 items, each rated on a scale of 0-4, with a total score range of 0-28 points. Evaluate the difference in scores between the Insomnia Severity Index (ISI) scale at the end of week 2 and baseline ISI scores.
Measured: 2 weeks
Menopause Rating Scale
Menopause Rating Scale（MRS） is a widely used tool in clinical practice and research to assess the type and severity of menopause-related symptoms, particularly the subjective experience over the past 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start20 Mar 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insomnia During Perimenopause and MenopauseStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongmei Huang, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229976
- Sponsor's protocol ID
- TJ-IRB202510056
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07229976
- Acronym / sponsor ID
- TJ-IRB202510056
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 17 Nov 2025 (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.
A multicenter, randomized, controlled, blinded clinical trial was conducted to evaluate the effects of thumbtack needle on sleep in patients with chronic insomnia during perimenopause and menopause. Randomly divided into a treatment group and a control group using the central area method, with 99 patients in each group. The treatment group received thumbtack needle treatment, while the control group received placebo thumbtack needle treatment. The treatment course for both groups was 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thumbtack needle group | Experimental | Other: thumbtack needleThe subject received thumbtack needle |
| Placebo thumbtack needle group | Other | Other: placebo thumbtack needleThe subject received placebo thumbtack needle |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 40 to 65 who meet the diagnostic criteria for perimenopause and menopause mentioned above;
- Evaluate ISI score ≥ 12 points through a scale;
- Meets the diagnostic criteria for chronic insomnia mentioned above, i.e. ICSD-3 meets both criteria A to F;
- Voluntarily participate in this study and sign an informed consent form.
Key exclusion criteria (14 listed)
- Patients who meet any of the following conditions will not be included;
- Use hormone replacement therapy, anti anxiety drugs, antidepressants, or medications to improve insomnia within one month;
- Individuals with a history of diagnosed sleep disorders before menopause;
- Combined with other sleep disorders such as obstructive sleep apnea, restless leg syndrome, etc;
- Patients with malignant tumors, especially estrogen dependent tumors (such as breast cancer and endometrial cancer);
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 |
|---|---|---|
| thumbtack needleThe treatment acupoints include bilateral Anmian Acupoint, bilateral Taichong acupoints, bilateral Neiguan acupoints, bilateral Sanyinjiao (SP6), and bilateral Zusanli (ST36) and Danzhong acupoints, a total of 11 acupoints. After 3 days of thumbtack needle retention, the patient went to the hospital where the doctor removed the thumbtack needle, disinfected the local skin, and received the next needle treatment. The patient received treatment twice a week (6 days) and rested for 1 day before continuing with the next treatment. | Other | thumbtack needle group |
| placebo thumbtack needleThe placebo thumbtack needle group selected acupoints that were the same as the thumbtack needle group. Bilateral sleeping acupoints, bilateral Taichong acupoints, bilateral Neiguan acupoints, bilateral Sanyinjiao (SP6), bilateral Zusanli (ST36), and Danzhong acupoints are all treated with comforting acupressure.where the doctor removed the placebo thumbtack needle, disinfected the local skin, and received the next placebo thumbtack needle needle. The patient received treatment twice a week (6 days) and rested for 1 day before continuing with the next treatment. | Other | Placebo thumbtack needle group |
Primary outcome
Insomnia Severity Index
Time frame: 4 weeks
The Insomnia Severity Index (ISI) is a self-assessment tool used to evaluate the severity of insomnia. The ISI scale consists of 7 items, each rated on a scale of 0-4, with a total score range of 0-28 points. Evaluate the difference in scores between the Insomnia Severity Index (ISI) scale at the end of week 4 and baseline ISI scores.
23 secondary outcomes
Pittsburgh sleep quality index
Time frame: 4 weeks
Epworth Sleepiness Scale
Time frame: 4 weeks
Fatigue Severity Scale
Time frame: 4 weeks
Zung Self Rating Anxiety Scale
Time frame: 4 weeks
Zung Self Rating Depression Scale
Time frame: 4 weeks
Sleep efficiency
Time frame: 2 weeks，4 weeks
wake-up time after sleep onset
Time frame: 2 weeks, 4 weeks
the number of awakenings per night
Time frame: 2 weeks, 4 weeks
The latent period of sleep onset
Time frame: 2 weeks, 4 weeks
Total sleep time
Time frame: 2 weeks, 4 weeks
the average wake-up time
Time frame: 2 weeks, 4weeks
Corticotropin-Releasing Hormone
Time frame: 4 weeks
Norepinephrine
Time frame: 4 weeks
Adrenaline
Time frame: 4 weeks
5-hydroxytryptamine
Time frame: 4 weeks
Gamma aminobutyric acid
Time frame: 4 weeks
Dopamine
Time frame: 4 weeks
Melatonin
Time frame: 4 weeks
β - endorphin
Time frame: 4 weeks
insomnia remission rate
Time frame: 4 weeks
Insomnia Treatment Response Rate
Time frame: 4 weeks
Insomnia Severity Index
Time frame: 2 weeks
Menopause Rating Scale
Time frame: 4 weeks
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 27 Oct 2026.
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thumbtack needle in people with Chronic Insomnia During Perimenopause and Menopause, run by Huazhong University of Science and Technology at 8 sites in China.
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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 4 weeks). 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 27 Oct 2026.