Insomnia Type; Sleep DisorderNCT04000113
Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women
A study testing laser acupuncture in people with Insomnia Type; Sleep Disorder and Perimenopausal Women, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Insomnia Type; Sleep Disorder, Perimenopausal Women
- What is being tested?
- laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Jen-Lin Yang, 886-2-28757453, jlyang@vghtpe.gov.tw
Fang-Pey Chen, 886-2-28757453, fpchen@vghtpe.gov.tw
About this study
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.
Read the 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.
- Being tested
- laser acupuncture, Sham laser
- Keywords
- menopause, insomnia, sleep disorder
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureDevice
low level laser emission on specific acupuncture points
Sham laserDevice
Sham laser
| Study group | Role | What they receive |
|---|---|---|
| laser acupuncture treatment | Experimental | Subjects accept low-dose near-infrared laser acupuncture (10mWx10) treatment for 5 minutes in each trial. Receives: Device: laser acupuncture |
| Sham laser acupuncture treatment | Sham comparator | Subjects accept the sham (blank) laser acupuncture treatment for 5 minutes in each trial. Receives: Device: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: scores change between baseline and after last treatment(two weeks and one month later)
Secondary outcomes (3)
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.
Measured: scores change between baseline and after last treatment(one month later)
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.
Measured: scores change between baseline and after last treatment(one month later)
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.
Measured: change of nLF and HFcomponents of HRV from baseline and after last treatment.(one month later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start24 Jun 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Type; Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Taipei Chinese Medical Association, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jen-Lin Yang, MD, PhD, Principal investigator, Center for Traditional Medicine,Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000113
- Sponsor's protocol ID
- 2019-04-005C
- Status last verified
- Aug 2019
- First submitted
- 19 May 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women : a Randomized, Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT04000113
- Acronym / sponsor ID
- 2019-04-005C
- Keywords
- menopause, insomnia, sleep disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Taipei Chinese Medical Association, Taiwan
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser acupuncture treatment | Experimental | Device: laser acupunctureSubjects accept low-dose near-infrared laser acupuncture (10mWx10) treatment for 5 minutes in each trial. |
| Sham laser acupuncture treatment | Sham comparator | Device: Sham laserSubjects accept the sham (blank) laser acupuncture treatment for 5 minutes in each trial. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser acupuncturelow level laser emission on specific acupuncture points | Device | laser acupuncture treatment |
| Sham laserSham laser | Device | Sham laser acupuncture treatment |
Primary outcome
the Pittsburgh Sleep Quality index (PSQI) questionnaire,
Time frame: scores change between baseline and after last treatment(one month later)
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).
the Insomnia Severe Index scale (ISI)
Time frame: scores change between baseline and after last treatment(two weeks and one month later)
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.
3 secondary outcomes
The Menopause Rating Scale (MRS)
Time frame: scores change between baseline and after last treatment(one month later)
The Beck Inventory Index scale (BDI-II)
Time frame: scores change between baseline and after last treatment(one month later)
The signal measurements of heart rate variability
Time frame: change of nLF and HFcomponents of HRV from baseline and after last treatment.(one month later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Lin Yang, MD, PhD principal investigator
Center for Traditional Medicine,Taipei Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture in people with Insomnia Type; Sleep Disorder and Perimenopausal Women, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jen-Lin Yang, MD, PhD (886-2-28757453, jlyang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Pittsburgh Sleep Quality index (PSQI) questionnaire, (time frame: scores change between baseline and after last treatment(one month later)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.