NCT04000113

Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women

Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women : a Randomized, Double-blind Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia Type; Sleep Disorder
• Perimenopausal Women

Interventions

Type	Name	Description
DEVICE	laser acupuncture	low level laser emission on specific acupuncture points
DEVICE	Sham laser	Sham laser

Timeline

• Start date: 2019-06-24
• Primary completion: 2020-05-01
• Completion: 2020-08-01
• First posted: 2019-06-27
• Last updated: 2019-08-06

Locations

1 site across 1 country: Taiwan