Insomnia Type; Sleep Disorder Clinical Trial
Official title:
Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women : a Randomized, Double-blind Controlled Study
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | August 1, 2020 |
| Est. primary completion date | May 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Taipei Veterans General Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Taipei Veterans General Hospital, Taiwan | Taipei Chinese Medical Association, Taiwan |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | sleep diary | The sleep diary provides daily subjective estimates of sleep parameters including: daytime nap, sleep aids intake, bedtime, sleep onset latency, frequency of nocturnal awakenings, awakenings duration, wake-up time, arising time, feeling upon arising (five-point scale) and sleep quality (five-point scale). | scores change between baseline and after last treatment(one month later) | |
| Primary | 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) | |
| Primary | 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 | The Menopause Rating Scale (MRS) | The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items (severity 0 [no complaints] 4 scoring points [very severe symptoms]). The respondent provides the subject's personal perception by checking one of 5 possible boxes of "severity" for each of the items. | scores change between baseline and after last treatment(one month later) | |
| Secondary | The Beck Inventory Index scale (BDI-II) | The BDI-II is a 21-item self-report measure of the severity of depressive symptomatology. Each of the 21 items is rated on a 4-point scale ranging from 0-3. The rating are summed, yielding a total score that can range from 0-63. | scores change between baseline and after last treatment(one month later) | |
| Secondary | The signal measurements of heart rate variability | Frequency-domain analysis of heart rate variability (HRV), a noninvasive method, has been used to reflect cardiac autonomic nervous activity in humans. The high-frequency power (HF; 0.15-0.4 Hz) of HRV represents vagal (parasympathetic) control of heart rate. The low-frequency power (LF; 0.04- 0.15 Hz) of HRV is jointly contributed by both sympathetic and vagal nerves, whereas normalized LF (nLF) is regarded as the sympathetic modulation.An elevated LF component and a decreased HF component of the HRV have been found in women with insomnia when they are compared with healthy women. | change of nLF and HFcomponents of HRV from baseline and after last treatment.(one month later) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05050292 -
Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia
|
N/A | |
| Recruiting |
NCT05173844 -
Digital Sleep Therapy for Older Adults With Cognitive Impairment
|
N/A | |
| Completed |
NCT05253417 -
The CANabidiol Use for RElief of Short Term Insomnia
|
Phase 2 | |
| Completed |
NCT03727906 -
Sleep and Cardiovascular Health in Adolescence
|
N/A | |
| Not yet recruiting |
NCT04677946 -
Dietary Oil to Improve Sleep Quality
|
N/A |