Evaluation of Laser Acupuncture on Health Promotion of Sub-health People

March 31, 2020 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Center for Traditional Medicine, Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Laser acupuncture
808nm low level laser therapy
Device: Low level laser therapy
808nm low level laser therapy on acupuncture points
SHAM_COMPARATOR: Sham laser acupuncture
no low level laser output but same device
Device: Low level laser therapy
808nm low level laser therapy on acupuncture points

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Change from Baseline Systolic Blood Pressure at 5 and 8 weeks
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
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
Change from Baseline Sleep Quality Index at 5 and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain waves
Time Frame: Change from Baseline Brain Waves at 5 and 8 weeks
Delta activity (0.5-4 Hz)、Theta activity (4-7 Hz) and alpha activity
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
Change from Baseline Heart Rate Variability at 5 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yen-Ying Kung, MD, Center for Traditional Medicine,Taipei Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-01-026CCF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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