The Effects of Acupuncture on Insomnia Among Midlife Women

NCT05684822 | Completed

• 1 other identifier: 20190101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menopause Syndrome

Keywords

Midlife Women; Acupuncture; Insomnia; Polysomnography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Hospital Anxiety and Depression Scale (HADS)

  15 minutes

• Epworth Sleepiness Scale (ESS)

  15 minutes

• Snore Outcomes Survey (SOS)

  15 minutes

• Global Physical Activity Questionnaire

  15 minutes

• Total sleep time (TST)

  8 hours

Study Arms (2)

The experimental group received acupuncture treatment

EXPERIMENTAL

The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance

Other: Acupuncture

The control group received subcutaneous sham acupuncture

SHAM COMPARATOR

The control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance.

Other: Acupuncture

Interventions

Acupuncture OTHER

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

The control group received subcutaneous sham acupuncture; The experimental group received acupuncture treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Ministry of Health and Welfare Tainan Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will not know that they are recieving acupuncture or sham acupuncture
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: January 13, 2023
• Study Start: January 1, 2019
• Primary Completion: August 19, 2019
• Study Completion: September 24, 2020
• Last Updated: January 13, 2023

Record last verified: 2022-10

Locations

TW (1)