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The Effects of Acupuncture on Insomnia Among Midlife Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05684822
Enrollment
42
Registered
2023-01-13
Start date
2019-01-01
Completion date
2020-09-24
Last updated
2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause Syndrome

Keywords

Midlife Women, Acupuncture, Insomnia, Polysomnography

Brief summary

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

Detailed description

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.

Interventions

OTHERAcupuncture

Acupoint:Taichong, Shenmen, Neiguan points with twice a week for total three weeks

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The patients will not know that they are recieving acupuncture or sham acupuncture

Intervention model description

This study is designed according to the Impaired Sleep Model, and is a single-blind randomized clinical trial.

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh sleep quality index (PSQI)15 minutesThe 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.

Secondary

MeasureTime frameDescription
Epworth Sleepiness Scale (ESS)15 minutesThe 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.
Snore Outcomes Survey (SOS)15 minutesThe SOS consists of 8 items relating to the intensity, duration, frequency, and impact of SDB symptoms - specifi cally snoring.
Global Physical Activity Questionnaire15 minutesThe 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)
Total sleep time (TST)8 hoursTST was determined as the number of minutes asleep in bed after lights off, considering only nighttime sleep.
Wake time after sleep onset (WASO)8 hoursWake time after sleep onset is time during which one is awake.
Hospital Anxiety and Depression Scale (HADS)15 minutesThe 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.
Percentage of rapid eye movement (REM) stage8 hoursREM sleep is the stage in which most people vividly dream. These periods of sleep typically start around 90 minutes after someone falls asleep.
Sleep efficiency (SE)8 hoursSleep 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.
Minimum spo2 level during sleep8 hoursA normal level of oxygen is usually 95% or higher. Some people with chronic lung disease or sleep apnea can have normal levels around 90%.
Mean heart rate during REM8 hoursRapid eye movement (REM) sleep is characterized by periods of profound cardiac autonomic activation evident in heart rate surges in humans and canines.
Sleep Latency8 hoursSleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026