Suboptimal Health StatusNCT04325945
Evaluation of Laser Acupuncture on Health Promotion of Sub-health People
A study testing Low level laser therapy in people with Suboptimal Health Status, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Background: Suboptimal health status (SHS) is a dynamic state wherein people have not been diagnosed with a disease but tend to develop diseases. People with SHS often experience fatigue and other nonspecific symptoms. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Suboptimal Health Status
- What is being tested?
- Low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2020to 31 Dec 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measure blood pressure at rest 120-139 / 80-89 mmHg more than 3 times a week.
- PSQI score greater than 5.
- Body mass index (BMI) :24~30 Kg/m2
Who cannot join
- Patients diagnosed with chronic diseases, such as hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, coronary heart disease and other diseases that fall into the scope of chronic diseases of universal health insurance.
- Diagnosis of mental illness.
- Cancer patient
- Pregnancy
- People with significant inflammation at the time of participation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Center for Traditional Medicine, Taipei Veterans General Hospital
Taipei, 112
Yenying Kung, MD, 886-2-28730502, yykung@vghtpe.gov.tw
About this study
Official title: Taipei Veterans General Hospital,Taiwan, R.O.C.
Background: Suboptimal health status (SHS) is a dynamic state wherein people have not been diagnosed with a disease but tend to develop diseases. People with SHS often experience fatigue and other nonspecific symptoms. Early TCM-based interventions in people with SHS can prevent them from developing chronic diseases, thereby reducing the burden on health insurance systems. No study has explored the effects of laser acupuncture (LA) on people with SHS.
Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires, physical status and objective sleep parameters will be assessed in treatment group and control group after the 16th session. In the second year protocol, seventy SHS subjects will be enrolled and same procedure will be performed as the first year protocol.
Read the detailed description
Background: Suboptimal health status (SHS) is a dynamic state. The term refers to an existing condition of ill health that could lead to a pathological condition but could also be eliminated, enabling the individual in question to return to a state of good health.
Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that preventive treatment for diseases is superior to curative treatment. Therefore, TCM intervention will be eliminated SHS becoming to a chronic disease. According to previous studies, people with SHS without sports habits have 8 times risk of developing hypertension. In addition, people with SHS have more rates of sleep disorders, which are associated with obstructive sleep apnea due to decreased oxygen maturation during sleep, than healthy subjects.
A cloud TCM health-care model, which is combined with constitution patterns in TCM and physiological parameters, applied to Taiwanese with SHS. Taiwanese with SHS, no matter yang deficiency, Ying deficiency or Phlegm-stasis patterns, have decreased cardiac parasympathetic activity and high frequency change in pulse power spectrum analysis at right Chi. This phenomenon implied that people with SHS reduced convergence of the ministerial fire in the gate of life and then developed a disharmonic status between "Heart" and "Kidney" in TCM. This theory can explain why SHS has sleep disorders and prehypertension.
Laser acupuncture (LA) has been used in preventive diseases and many effects. Modern researches showed LA improved insomnia, circulation, analgesia and metabolism. However, it is still lacking evidences of objective parameters of sleep and there are no studies about TCM patterns change in SHS by LA.
In this study, the effects of 8 weeks' LA intervention on people with SHS presented with pre-hypertension and/or sleep disorders by a cloud health-care system combined with TCM patterns and physiological parameters will be investigated by 2-years protocols. The result will be helpful to establish the role of LA for preventive medicine in Taiwan.
Hypothesis: Regular LA intervention can improve sleep quality and regulate blood pressure and autonomic nervous function of sub-healthy people. Moreover, combining the cloud-based TCM body constitution and physical healthcare system can help sub-healthy people manage their own health better.
Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and will be assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires will assessed in treatment group and control group before the first session and after the 16th session. In addition, we using mobile cloud-based devices to assess the physical status, such as blood pressure, blood oxygen saturation, physical activity, pulse signal, tongue examination, and autonomic nervous function before and after each sessions. Furthermore, sleep patterns will assessed for at least 2 days.
In the second year protocol, seventy SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled. and assigned into a experiment group and a control group randomly. The evaluation methods are the same as the first year protocol. Besides, we will build up the cloudy system to present body constitution scores and objective parameters. The auto-feedback function will be established in the second year protocol.
- Conditions
- Suboptimal Health Status
- Being tested
- Low level laser therapy
- Keywords
- pre-hypertension, insomnia, obesity
- Medical subject headings
- Prehypertension, Sleep Initiation and Maintenance Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
808nm low level laser therapy on acupuncture points
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture | Experimental | 808nm low level laser therapy Receives: Device: Low level laser therapy |
| Sham laser acupuncture | Sham comparator | no low level laser output but same device Receives: Device: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Change from Baseline Systolic Blood Pressure at 5 and 8 weeks
Body mass index
Measured: Change from Baseline Body Mass Index at 5 and 8 weeks
Sleep quality
Pittsburgh sleep quality index
Measured: Change from Baseline Sleep Quality Index at 5 and 8 weeks
Secondary outcomes (2)
Brain waves
Delta activity (0.5-4 Hz)、Theta activity (4-7 Hz) and alpha activity
Measured: Change from Baseline Brain Waves at 5 and 8 weeks
Heart rate variability
Measured: Change from Baseline Heart Rate Variability at 5 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suboptimal Health StatusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Yen-Ying Kung, MD, Principal investigator, Center for Traditional Medicine,Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325945
- Sponsor's protocol ID
- 2020-01-026CCF
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei Veterans General Hospital,Taiwan, R.O.C.
- ClinicalTrials.gov ID
- NCT04325945
- Acronym / sponsor ID
- 2020-01-026CCF
- Conditions
- Suboptimal Health Status
- Keywords
- pre-hypertension, insomnia, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Mar 2020 (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.
Background: Suboptimal health status (SHS) is a dynamic state wherein people have not been diagnosed with a disease but tend to develop diseases. People with SHS often experience fatigue and other nonspecific symptoms. Early TCM-based interventions in people with SHS can prevent them from developing chronic diseases, thereby reducing the burden on health insurance systems. No study has explored the effects of laser acupuncture (LA) on people with SHS.
Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires, physical status and objective sleep parameters will be assessed in treatment group and control group after the 16th session. In the second year protocol, seventy SHS subjects will be enrolled and same procedure will be performed as the first year protocol.
Detailed description
Background: Suboptimal health status (SHS) is a dynamic state. The term refers to an existing condition of ill health that could lead to a pathological condition but could also be eliminated, enabling the individual in question to return to a state of good health.
Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that preventive treatment for diseases is superior to curative treatment. Therefore, TCM intervention will be eliminated SHS becoming to a chronic disease. According to previous studies, people with SHS without sports habits have 8 times risk of developing hypertension. In addition, people with SHS have more rates of sleep disorders, which are associated with obstructive sleep apnea due to decreased oxygen maturation during sleep, than healthy subjects.
A cloud TCM health-care model, which is combined with constitution patterns in TCM and physiological parameters, applied to Taiwanese with SHS. Taiwanese with SHS, no matter yang deficiency, Ying deficiency or Phlegm-stasis patterns, have decreased cardiac parasympathetic activity and high frequency change in pulse power spectrum analysis at right Chi. This phenomenon implied that people with SHS reduced convergence of the ministerial fire in the gate of life and then developed a disharmonic status between "Heart" and "Kidney" in TCM. This theory can explain why SHS has sleep disorders and prehypertension.
Laser acupuncture (LA) has been used in preventive diseases and many effects. Modern researches showed LA improved insomnia, circulation, analgesia and metabolism. However, it is still lacking evidences of objective parameters of sleep and there are no studies about TCM patterns change in SHS by LA.
In this study, the effects of 8 weeks' LA intervention on people with SHS presented with pre-hypertension and/or sleep disorders by a cloud health-care system combined with TCM patterns and physiological parameters will be investigated by 2-years protocols. The result will be helpful to establish the role of LA for preventive medicine in Taiwan.
Hypothesis: Regular LA intervention can improve sleep quality and regulate blood pressure and autonomic nervous function of sub-healthy people. Moreover, combining the cloud-based TCM body constitution and physical healthcare system can help sub-healthy people manage their own health better.
Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and will be assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires will assessed in treatment group and control group before the first session and after the 16th session. In addition, we using mobile cloud-based devices to assess the physical status, such as blood pressure, blood oxygen saturation, physical activity, pulse signal, tongue examination, and autonomic nervous function before and after each sessions. Furthermore, sleep patterns will assessed for at least 2 days.
In the second year protocol, seventy SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled. and assigned into a experiment group and a control group randomly. The evaluation methods are the same as the first year protocol. Besides, we will build up the cloudy system to present body constitution scores and objective parameters. The auto-feedback function will be established in the second year protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture | Experimental | Device: Low level laser therapy808nm low level laser therapy |
| Sham laser acupuncture | Sham comparator | Device: Low level laser therapyno low level laser output but same device |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Measure blood pressure at rest 120-139 / 80-89 mmHg more than 3 times a week.
- PSQI score greater than 5.
- Body mass index (BMI) :24~30 Kg/m2
Key exclusion criteria (5 listed)
- Patients diagnosed with chronic diseases, such as hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, coronary heart disease and other diseases that fall into the scope of chronic diseases of universal health insurance.
- Diagnosis of mental illness.
- Cancer patient
- Pregnancy
- People with significant inflammation at the time of participation.
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 |
|---|---|---|
| Low level laser therapy808nm low level laser therapy on acupuncture points | Device | Laser acupuncture, Sham laser acupuncture |
Primary outcome
Blood pressure
Time frame: Change from Baseline Systolic Blood Pressure at 5 and 8 weeks
Body mass index
Time frame: Change from Baseline Body Mass Index at 5 and 8 weeks
Sleep quality
Time frame: Change from Baseline Sleep Quality Index at 5 and 8 weeks
Pittsburgh sleep quality index
2 secondary outcomes
Brain waves
Time frame: Change from Baseline Brain Waves at 5 and 8 weeks
Heart rate variability
Time frame: Change from Baseline Heart Rate Variability at 5 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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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.
Yen-Ying Kung, MD 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 Low level laser therapy in people with Suboptimal Health Status, 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 3 inclusion and 5 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 1 Apr 2020. 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 Yen-Ying Kung, MD (886-2-28757453 ext. 215, yykung@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Change from Baseline Systolic Blood Pressure at 5 and 8 weeks). The study lists 3 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 1 Apr 2020.