Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women

NCT04000113 | Unknown

• 1 other identifier: 2019-04-005C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Type; Sleep Disorder; Perimenopausal Women

Keywords

menopause; insomnia; sleep disorder

Outcome Measures

Primary Outcomes (2)

• the Pittsburgh Sleep Quality index (PSQI) questionnaire,

  The 2I-item PSQI yields a global score, which represents the sum of seven individual component scores: sUbjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances (including items such as feeling pain, having difficulty breathing), use of medications for sleep and daytime dysfunction (including items related to daytime sleepiness and energy).

  scores change between baseline and after last treatment(one month later)

• the Insomnia Severe Index scale (ISI)

  The Insomnia Severity Index (ISI) is composed of seven items that evaluate: (a) the severity of sleep-onset (initial), (b) sleep maintenance (middle), (c) early morning awakening (terminal) problems, (d) satisfaction with current sleep pattern, (e) interference with daily functioning, (f) noticeability of impairment attributed to the sleep problem, and (g) level of distress caused by the sleep problem. Each of these items is rated on a five-point Likert scale ("0" = not at all, "4"= extremely) and the time interval is "in the last 2 weeks". Total scores range from 0 to 28, with high scores indicating greater insomnia severity.

  scores change between baseline and after last treatment(two weeks and one month later)

Secondary Outcomes (3)

• The Menopause Rating Scale (MRS)

  scores change between baseline and after last treatment(one month later)

• The Beck Inventory Index scale (BDI-II)

  scores change between baseline and after last treatment(one month later)

• The signal measurements of heart rate variability

  change of nLF and HFcomponents of HRV from baseline and after last treatment.(one month later)

Other Outcomes (1)

• sleep diary

  scores change between baseline and after last treatment(one month later)

Study Arms (2)

laser acupuncture treatment

EXPERIMENTAL

Subjects accept low-dose near-infrared laser acupuncture (10mWx10) treatment for 5 minutes in each trial.

Device: laser acupuncture

Sham laser acupuncture treatment

SHAM COMPARATOR

Subjects accept the sham (blank) laser acupuncture treatment for 5 minutes in each trial.

Device: Sham laser

Interventions

laser acupuncture DEVICE

low level laser emission on specific acupuncture points

laser acupuncture treatment

Sham laser DEVICE

Sham laser

Sham laser acupuncture treatment

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: peri-menopausal transition
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Taipei Chinese Medical Association, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Jen-Lin Yang, MD, PhD

  Center for Traditional Medicine,Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen-Lin Yang, MD, PhD

CONTACT

886-2-28757453; jlyang@vghtpe.gov.tw

Fang-Pey Chen, MD, A.P.

CONTACT

886-2-28757453; fpchen@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: June 27, 2019
• Study Start: June 24, 2019
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)