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The Effects of Acupuncture on Insomnia Among Midlife Women

Primary Purpose

Menopause Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause Syndrome focused on measuring Midlife Women, Acupuncture, Insomnia, Polysomnography

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ministry of Health and Welfare Tainan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

The experimental group received acupuncture treatment

The control group received subcutaneous sham acupuncture

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Snore Outcomes Survey (SOS)
The SOS consists of 8 items relating to the intensity, duration, frequency, and impact of SDB symptoms - specifi cally snoring.
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)
Total sleep time (TST)
TST was determined as the number of minutes asleep in bed after "lights off," considering only nighttime sleep.
Wake time after sleep onset (WASO)
Wake time after sleep onset is time during which one is awake.
Sleep Latency
Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.
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.
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.
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%.
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.

Full Information

First Posted
October 14, 2022
Last Updated
January 5, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05684822
Brief Title
The Effects of Acupuncture on Insomnia Among Midlife Women
Official Title
The Effects of Acupuncture on Insomnia Among Midlife Women: A Randomized Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
September 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause Syndrome
Keywords
Midlife Women, Acupuncture, Insomnia, Polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is designed according to the Impaired Sleep Model, and is a single-blind randomized clinical trial.
Masking
Participant
Masking Description
The patients will not know that they are recieving acupuncture or sham acupuncture
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The experimental group received acupuncture treatment
Arm Type
Experimental
Arm Description
The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance
Arm Title
The control group received subcutaneous sham acupuncture
Arm Type
Sham Comparator
Arm Description
The control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupoint:Taichong, Shenmen, Neiguan points with twice a week for total three weeks
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index (PSQI)
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
15 minutes
Title
Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
15 minutes
Title
Snore Outcomes Survey (SOS)
Description
The SOS consists of 8 items relating to the intensity, duration, frequency, and impact of SDB symptoms - specifi cally snoring.
Time Frame
15 minutes
Title
Global Physical Activity Questionnaire
Description
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)
Time Frame
15 minutes
Title
Total sleep time (TST)
Description
TST was determined as the number of minutes asleep in bed after "lights off," considering only nighttime sleep.
Time Frame
8 hours
Title
Wake time after sleep onset (WASO)
Description
Wake time after sleep onset is time during which one is awake.
Time Frame
8 hours
Title
Sleep Latency
Description
Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.
Time Frame
8 hours
Title
Percentage of rapid eye movement (REM) stage
Description
REM sleep is the stage in which most people vividly dream. These periods of sleep typically start around 90 minutes after someone falls asleep.
Time Frame
8 hours
Title
Sleep efficiency (SE)
Description
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.
Time Frame
8 hours
Title
Minimum spo2 level during sleep
Description
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%.
Time Frame
8 hours
Title
Mean heart rate during REM
Description
Rapid eye movement (REM) sleep is characterized by periods of profound cardiac autonomic activation evident in heart rate surges in humans and canines.
Time Frame
8 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ministry of Health and Welfare Tainan Hospital
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

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The Effects of Acupuncture on Insomnia Among Midlife Women

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