The Effects of Acupuncture on Insomnia Among Midlife Women

Study Overview
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Brief Summary
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Aims: To explore the effects of acupuncture on the improvement of insomnia, fatigue, depression and menopausal symptoms among midlife women.

Detailed Description
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This research is a study with a randomized clinical trial. Participants were 40-60 years old with a sleep disturbance which persists more than one month. Twenty participants were randomly assigned into the experimental and control groups. The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance; the control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance. All participants received pre-test and post-test, including sleep multiple physiological examination (PSG), Pittsburgh sleep quality table, Epworth sleepiness scale, hospital anxiety depression scale, menopausal symptom questionnaire, sleep disturbance comprehensive scale, and wore Actiwatch for three days. Data analysis was performed using SPSS.

Official Title
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The Effects of Acupuncture on Insomnia Among Midlife Women: A Randomized Clinical Trail

Conditions
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Menopause Syndrome

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 40-60 years Complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning The score of sleep disorder on the Pittsburgh Sleep Quality Scale was more than 5 points Exclusion Criteria: History of psychiatric disorders History of sleep apnea or nocturnal myoclonus Center or neurodegenerative disease Cancer Melatonin or sleeping pills use in the past month

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is designed according to the Impaired Sleep Model, and is a single-blind randomized clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental group received acupuncture treatment<br>The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance | Other: Acupuncture<br>* Acupoint:Taichong, Shenmen, Neiguan points with twice a week for total three weeks<br>|
| Sham Comparator: The control group received subcutaneous sham acupuncture<br>The control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance. | Other: Acupuncture<br>* Acupoint:Taichong, Shenmen, Neiguan points with twice a week for total three weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index (PSQI) | The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general people. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that has been found to be a reliable instrument for detecting states of anxiety and depression in the setting of hospital outpatient clinic. | 15 minutes | 
| Epworth Sleepiness Scale (ESS) | The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. | 15 minutes | 
| Snore Outcomes Survey (SOS) | The SOS consists of 8 items relating to the intensity, duration, frequency, and impact of SDB symptoms - specifi cally snoring. | 15 minutes | 
| Global Physical Activity Questionnaire | The Global Physical Activity Questionnaire was developed by WHO for physical activity surveillance in countries. It collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions (P1-P16) | 15 minutes | 
| Total sleep time (TST) | TST was determined as the number of minutes asleep in bed after lights off, considering only nighttime sleep. | 8 hours | 
| Wake time after sleep onset (WASO) | Wake time after sleep onset is time during which one is awake. | 8 hours | 
| Sleep Latency | Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out. | 8 hours | 
| Percentage of rapid eye movement (REM) stage | REM sleep is the stage in which most people vividly dream. These periods of sleep typically start around 90 minutes after someone falls asleep. | 8 hours | 
| Sleep efficiency (SE) | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), plays a central role in insomnia research and practice. The significance of SE is understandable because it captures a core problem for those suffering from insomnia-spending too much time in bed trying to sleep. | 8 hours | 
| Minimum spo2 level during sleep | A normal level of oxygen is usually 95% or higher. Some people with chronic lung disease or sleep apnea can have normal levels around 90%. | 8 hours | 
| Mean heart rate during REM | Rapid eye movement (REM) sleep is characterized by periods of profound cardiac autonomic activation evident in heart rate surges in humans and canines. | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midlife Women, Acupuncture, Insomnia, Polysomnography