The Effects of Acupuncture on Insomnia Among Midlife Women

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

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

Study Overview

• Status: Completed
• Conditions: Menopause Syndrome
• Intervention / Treatment: Other: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Ministry of Health and Welfare Tainan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): September 24, 2020

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Estimate): January 13, 2023

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; Polysomnography; Insomnia; Midlife Women
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 20190101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No