Back to resultsThe Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
Primary Purpose
Primary Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the tiaoshen acupuncture
the common acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring acupuncture, Primary Insomnia, RCT
Eligibility Criteria
Inclusion Criteria: Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia; Age range: 18-70 years old; PSQI score>7 points; No communication and cognitive impairment; No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases; Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV; Sign an informed consent form prior to the start of the study. Exclusion Criteria: Those who do not meet the inclusion criteria; Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness; Those with severe liver and renal insufficiency and bleeding tendencies; Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs; People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders; Pregnant or nursing; Those with other major diseases and poor control; Other persons who are unwilling to sign informed consent.
Sites / Locations
- The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the treatment group
the control group
Arm Description
the patients included in this arm will recept the tiaoshen acupuncture.
the patients included in this arm will recept treatment of acupuncture which described in book of Acupuncture and Moxibustion (the fifth edition of the new century)
Outcomes
Primary Outcome Measures
Pittsburgh sleep quality index
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Pittsburgh sleep quality index
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Pittsburgh sleep quality index
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data.The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Secondary Outcome Measures
Fatigue Scale-14
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Fatigue Scale-14
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Fatigue Scale-14
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Epworth Sleepiness Scale
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Epworth Sleepiness Scale
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Epworth Sleepiness Scale
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Self-Rating Anxiety Scale
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Self-Rating Anxiety Scale
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Self-Rating Anxiety Scale
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Self-rating depression scale
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Self-rating depression scale
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Self-rating depression scale
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Polysomnography
Polysomnography refers to the continuous and synchronous acquisition, recording and analysis of EEG, electrooculogram, electromyogram, oronasal airflow, respiratory effort, and saturation of oxygen levels, body position and other physiological and pathological parameters during sleep by sleep technicians all night through computer software in the sleep laboratory. This technology for the diagnosis of sleep disorders is the gold standard for the diagnosis and treatment of sleep disorders.
Heart rate variability
Heart rate variability (HRV) refers to the fluctuations in the interval between successive heartbeats. It is commonly used to evaluate the regulatory role of the autonomic nervous system on cardiac activity. It is an important noninvasive indicator for evaluating autonomic nervous activity, and is also one of the important indicators for evaluating autonomic nervous changes during sleep.
Full Information
NCT ID
NCT05830877
First Posted
April 1, 2023
Last Updated
June 22, 2023
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05830877
Brief Title
The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
Official Title
The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the treatment group adopts mind-regulating acupuncture, and the control group adopts routine acupuncture, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
acupuncture, Primary Insomnia, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the treatment group
Arm Type
Experimental
Arm Description
the patients included in this arm will recept the tiaoshen acupuncture.
Arm Title
the control group
Arm Type
Active Comparator
Arm Description
the patients included in this arm will recept treatment of acupuncture which described in book of Acupuncture and Moxibustion (the fifth edition of the new century)
Intervention Type
Other
Intervention Name(s)
the tiaoshen acupuncture
Intervention Description
The primary choice is to puncture GB20 with a quick puncture, which means "regulate the mind and open the way". ①Scalp acupuncture: Du 20(Baihui), EX-HN 3(Yintang), EX-HNl(Sishencong); ②Select acupoints from six acupoints for mind-regulating, ear points (both sides): heart, lung, and Shenmen; body points (both sides): LI20(Yingxiang), EXTRA 12(Anmian), ST36(Zusanli) as the main hole. ③Sleeping three needles(both sides): HT7(Shenmen), PC6(Neiguan), SP6(Sanyinjiao); ④Opening four gates: LI4(Hegu) , LR3(Taichong) ⑤Abdominal four needles:ST25(Tianshu), CV12(Zhongwan), CV4(Guanyuan). For body acupuncture, a 0.3 mm×40 mm needle was used to insert directly for 0.5-1.0 cun, and twisting to gain the qi; for auricular points, a 0.25 mm×40 mm needle was used for 2-3 minutes without manipulating the needle. The acupuncture points were retained for 30 min, and the treatment was performed once every other day, three times a week, and the curative effect was evaluated after 4 weeks of treatment.
Intervention Type
Other
Intervention Name(s)
the common acupuncture
Intervention Description
According to the "Insomnia" section in the textbook "Acupuncture and Moxibustion (New Century Fifth Edition)", the acupoints are selected as follows: GV20(Baihui), HT7(Shenmen), SP6(Sanyinjiao), KI6(Zhaohai), BL62(Shenmai), EX-HN22(Anmian), using a 0.3 mm×40 mm needle straight insert in skin with depth of 0.5-1.0 cun. After twisting to get qi, the researcher will manipulate the needle, and keep the needle in acupoints for 30 minutes.
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index
Description
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Time Frame
Before treatment
Title
Pittsburgh sleep quality index
Description
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Time Frame
the 4th week of treatment
Title
Pittsburgh sleep quality index
Description
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data.The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Time Frame
4 weeks after treatment
Secondary Outcome Measure Information:
Title
Fatigue Scale-14
Description
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Time Frame
Before treatment
Title
Fatigue Scale-14
Description
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Time Frame
the 4th week of treatment
Title
Fatigue Scale-14
Description
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Time Frame
4 weeks after treatment
Title
Epworth Sleepiness Scale
Description
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Time Frame
Before treatment
Title
Epworth Sleepiness Scale
Description
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Time Frame
he 4th week of treatment
Title
Epworth Sleepiness Scale
Description
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Time Frame
4 weeks after treatment
Title
Self-Rating Anxiety Scale
Description
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Time Frame
Before treatment
Title
Self-Rating Anxiety Scale
Description
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Time Frame
4th week of treatment
Title
Self-Rating Anxiety Scale
Description
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Time Frame
4 weeks after treatment
Title
Self-rating depression scale
Description
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Time Frame
Before treatment
Title
Self-rating depression scale
Description
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Time Frame
the 4th week of treatment
Title
Self-rating depression scale
Description
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Time Frame
4 weeks after treatment
Title
Polysomnography
Description
Polysomnography refers to the continuous and synchronous acquisition, recording and analysis of EEG, electrooculogram, electromyogram, oronasal airflow, respiratory effort, and saturation of oxygen levels, body position and other physiological and pathological parameters during sleep by sleep technicians all night through computer software in the sleep laboratory. This technology for the diagnosis of sleep disorders is the gold standard for the diagnosis and treatment of sleep disorders.
Time Frame
the 4th week of treatment
Title
Heart rate variability
Description
Heart rate variability (HRV) refers to the fluctuations in the interval between successive heartbeats. It is commonly used to evaluate the regulatory role of the autonomic nervous system on cardiac activity. It is an important noninvasive indicator for evaluating autonomic nervous activity, and is also one of the important indicators for evaluating autonomic nervous changes during sleep.
Time Frame
the 4th week of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
Age range: 18-70 years old;
PSQI score>7 points;
No communication and cognitive impairment;
No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;
Sign an informed consent form prior to the start of the study.
Exclusion Criteria:
Those who do not meet the inclusion criteria;
Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
Those with severe liver and renal insufficiency and bleeding tendencies;
Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
Pregnant or nursing;
Those with other major diseases and poor control;
Other persons who are unwilling to sign informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingjun Liu, DR.
Phone
15958033054
Email
frankly120@163.com
Facility Information:
Facility Name
The Third Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjun Liu, Doctor
Phone
15958033054
Email
20185003@zcmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
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