NCT04000113

Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women

Status unknown NA Last updated 6 August 2019

What this trial tests

NA trial testing laser acupuncture in Insomnia Type; Sleep Disorder in 60 participants. Status unknown.

Timeline

24 June 2019

Primary endpoint
1 May 2020

1 August 2020

Quick facts

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	24 June 2019
Primary completion	1 May 2020
Estimated completion	1 August 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• laser acupuncture
• Sham laser

Conditions studied

• Insomnia Type; Sleep Disorder — all drugs for Insomnia Type; Sleep Disorder →
• Perimenopausal Women — all drugs for Perimenopausal Women →

Sponsor

Taipei Veterans General Hospital, Taiwan

Who can join

Adults 45 to 60, female only, with Insomnia Type; Sleep Disorder or Perimenopausal Women. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.