Clinical trial NCT04000113: Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women
Official title: Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women : a Randomized, Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia Type; Sleep Disorder
Perimenopausal Women
Keywords: menopause
insomnia
sleep disorder
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Taipei Chinese Medical Association, Taiwan
First posted: 2019-06-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to previous studies, the quality of subjective sleep in women is generally worse than that of men. Although studies have shown that menopausal women who use hormone therapy can improve sleep disorders, the limited benefits of hormone therapy are reported, the duration of treatment and efficacy required is uncertain. The suspicions of the safety of hormone therapy have deterred many menopausal women.

Systematic review and meta-analysis show that acupuncture and related therapies (including electro-acupuncture, ear needle, body acupoint massage and ear acupoint massage, etc.) used in the study of insomnia treatment have a significant therapeutic effect. However, for the reason that most of them are invasive treatments, patients receiving such treatment are often afraid and hesitated. This study will apply the low-energy laser acupuncture treatment trials to menopausal women with insomnia. Sixty perimenopausal female volunteer subjects with 45-60 years of age who have been assessed and screened for sleep disorders will be recruited and participate in this experiment. After completing the basic data and various related scales, the subjects will undergo a double-blind, randomly allocated and controlled clinical trials. The experimental procedure is that the subjects will be placed in a soundproof, lying on a comfortable bed. After the instruments setting ready, subject receives the monitoring of 5-minute heart rate variability (HRV) measurements before and after the near-infrared laser acupuncture (10mWx10) treatment, a total of 30 minutes experimental process. The results of the analysis will be based on the Pittsburgh Sleep Quality index (PSQI) questionnaire, the Insomnia Severe Index scale (ISI) data as the main assessment results for analysis. The Menopause Rating Scale, (MRS), the Beck Depression Inventory Index scale (BDI-II) and the signal measurements of heart rate variability will be analyzed as secondary assessment grounds. Data of the questionnaires will be analyzed by the statistical method of Pair-t test for the comparison of the data before and after trial. The signal data of heart rate variability are analyzed by the two way ANOVA method. We expect that by way of combination of low-energy laser light irradiation method and theory of effective acupoints for insomnia can effectively improve the quality of sleep in peri-menopausal women.

Detailed description: According to previous studies, the quality of subjective sleep in women is generally worse than that of men. The prevalence rate can be dramatically increased from 30% before menopause to 50% during menopausal transition. Although studies have shown that menopausal women who use hormone therapy can improve sleep disorders caused by hot flashes, night sweats, sleep disorders, such as sleep apnea, the limited benefits of hormone therapy are reported, the duration of treatment and efficacy required is uncertain. The doubts about the safety of hormone therapy have deterred many menopausal women.

Systematic review and meta-analysis show that acupuncture and related therapies (including electroacupuncture, ear needle, body acupoint massage and ear acupoint massage, etc.) used in the study of insomnia treatment have a significant therapeutic effect. However, for the reason that most of them are invasive treatments, patients receiving such treatment are often afraid and hesitated. This study will apply the low-energy laser acupuncture treatment trials to menopausal women with insomnia. Sixty perimenopausal female volunteer subjects with 45-60 years of age who have been assessed and screened for sleep disorders will be recruited and participate in this experiment. After completing the basic data and various related scales, the subjects will undergo a double-blind, randomly allocated and controlled clinical trials. The experimental procedure is that the subjects will be placed in a soundproof, undisturbed clinic room, lying on a comfortable bed and a pillow and covered by a thin blanket. After the instruments setting ready, subject lie by first for 10 minutes, then a 5-minute heart rate variability (HRV) measurement recording is underwent, followed by low-dose near-infrared laser acupuncture (10mWx10) treatment for 5 minutes, then subject lie by again for 5 minutes, and another 5 minutes of heart rate variability instrument recording followed, a total of 30 minutes experimental process. Acupoints of treatment will include both sides of the Sleep 1 (EXTRA-1), both sides of the Neiguan (PC-6), both sides of Shemen (HT-7), both sides of the Sanyinjiao (SP-3), both sides of the Taichung (LI-3),total of 10 acupoints. The results of the analysis will be based on the Pittsburgh Sleep Quality index (PSQI) questionnaire, the Insomnia Severe Index scale (ISI) data as the main assessment results for analysis. The Menopause Rating Scale, (MRS), the Beck Drepression Inventory Index scale (BDI-II) and the signal measurements of heart rate variability will be analyzed as secondary assessment grounds. Data of the questionnaires will be analyzed by the statistical method of Pair-t test for the comparison of the data before and after trial. The signal data of heart rate variability are analyzed by the two way ANOVA method. We expect that by way of combination of low-energy laser light irradiation method and theory of effective acupoint for insomnia can effectively improve the quality of sleep in perimenopausal women. The experiment will start on June, 2019.

Eligibility criteria: Inclusion Criteria:

* age of 45-60,irregular menstruation cycle at least 3 months or menopause for one year.
* clinical symptoms of insomnia attack 3times per-week for at least 3 months
* no hormone replacement therapy at least one month
* no problem on intellectual or text, verbal communication
* informed consent given

Exclusion Criteria:

* epilepsy, diabetic neuropathy,arrythmia, CAD, abnormal blood pressure, severe renal disease, several liver disease, endocrine or metabolic disease,malignant tumor disease, dermal diseae or cancer
* acute or infectious disease, fever.
* neurosensory or perception disturbance, inflammatory painful disease which affect sleep quality.
* depression, anxiety, schizophrenia or other psychological problem.
* parasomnia, obstructive sleep apnoea,rapid eye movement sleep disorder and restless legs syndrome.
* lifestyle without sleep routine
* hypnotics dependent for 6 months.
* any medicine or therapy for problem of menopause and autonomic nerve system in one month.
* photophobia
* drug, alcohol,caffeine abuse.
* attending any clinical trial for 3 months.
* coagulation disturbance

Primary outcomes:
measure: the Pittsburgh Sleep Quality index (PSQI) questionnaire,
timeFrame: scores change between baseline and after last treatment(one month later)
measure: the Insomnia Severe Index scale (ISI)
timeFrame: scores change between baseline and after last treatment(two weeks and one month later)
Secondary outcomes:
measure: The Menopause Rating Scale (MRS)
timeFrame: scores change between baseline and after last treatment(one month later)
measure: The Beck Inventory Index scale (BDI-II)
timeFrame: scores change between baseline and after last treatment(one month later)
measure: The signal measurements of heart rate variability
timeFrame: change of nLF and HFcomponents of HRV from baseline and after last treatment.(one month later)
Other outcomes:
measure: sleep diary
timeFrame: scores change between baseline and after last treatment(one month later)
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Center for Traditional Medicine,Taipei Veterans General Hospital
name: Jen-Lin Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: