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Completed

NCT Number: NCT05684822

The Effects of Acupuncture on Insomnia Among Midlife Women

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

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Key information

Conditions

Menopause Syndrome Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health and Welfare Tainan Hospital

Tainan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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

Primary outcomes

  1. Pittsburgh sleep quality index (PSQI)

    Time frame: 15 minutes

    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 outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 15 minutes

    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.

  2. Epworth Sleepiness Scale (ESS)

    Time frame: 15 minutes

    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.

  3. Snore Outcomes Survey (SOS)

    Time frame: 15 minutes

    The SOS consists of 8 items relating to the intensity, duration, frequency, and impact of SDB symptoms - specifi cally snoring.

  4. Global Physical Activity Questionnaire

    Time frame: 15 minutes

    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)

  5. Total sleep time (TST)

    Time frame: 8 hours

    TST was determined as the number of minutes asleep in bed after "lights off," considering only nighttime sleep.

  6. Wake time after sleep onset (WASO)

    Time frame: 8 hours

    Wake time after sleep onset is time during which one is awake.

  7. Sleep Latency

    Time frame: 8 hours

    Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.

  8. Percentage of rapid eye movement (REM) stage

    Time frame: 8 hours

    REM sleep is the stage in which most people vividly dream. These periods of sleep typically start around 90 minutes after someone falls asleep.

  9. Sleep efficiency (SE)

    Time frame: 8 hours

    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.

  10. Minimum spo2 level during sleep

    Time frame: 8 hours

    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%.

  11. Mean heart rate during REM

    Time frame: 8 hours

    Rapid eye movement (REM) sleep is characterized by periods of profound cardiac autonomic activation evident in heart rate surges in humans and canines.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 13, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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