Clinical trial NCT05684822: 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
Overall status: COMPLETED
Phase: NA
Conditions: Menopause Syndrome
Keywords: Midlife Women
Acupuncture
Insomnia
Polysomnography
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 42
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed according to the Impaired Sleep Model, and is a single-blind randomized clinical trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 15 minutes
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 15 minutes
measure: Snore Outcomes Survey (SOS)
timeFrame: 15 minutes
measure: Global Physical Activity Questionnaire
timeFrame: 15 minutes
measure: Total sleep time (TST)
timeFrame: 8 hours
measure: Wake time after sleep onset (WASO)
timeFrame: 8 hours
measure: Sleep Latency
timeFrame: 8 hours
measure: Percentage of rapid eye movement (REM) stage
timeFrame: 8 hours
measure: Sleep efficiency (SE)
timeFrame: 8 hours
measure: Minimum spo2 level during sleep
timeFrame: 8 hours
measure: Mean heart rate during REM
timeFrame: 8 hours
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Ministry of Health and Welfare Tainan Hospital
Study officials:
References: