The Effects of Acupuncture on Insomnia Among Midlife Women

Menopause Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684822
• Other study ID #: 20190101
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 24, 2020

Study information

• Verified date: October 2022
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 24, 2020
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause Syndrome
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Taiwan	Ministry of Health and Welfare Tainan Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total sleep time (TST)	TST was determined as the number of minutes asleep in bed after "lights off," considering only nighttime sleep.	8 hours
Secondary	Wake time after sleep onset (WASO)	Wake time after sleep onset is time during which one is awake.	8 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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