The Effects of Acupuncture on Insomnia Among Midlife Women

NCT ID: NCT05684822

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupuncture

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ministry of Health and Welfare Tainan Hospital

Tainan City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20190101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fire Dragon Pot Moxibustion
NCT05234814 COMPLETED NA
Self-acupressure for Insomnia
NCT03053648 UNKNOWN NA
Acupuncture for Primary Insomnia
NCT00839592 COMPLETED NA