insomnia disorder
Conditions
Interventions
Healthy Volunteer Natural Breathing Group:Natural breathing method
Healthy Volunteer Six-Character Formula Slow Breathing Group:The Six-character Formula slow breathing method
taVNS treatment group of healthy volunteers:taVNS treatment
Healthy volunteer taVNS combined with the Six-Character Formula slow breathing treatment group:taVNS combined with the Six-Character Formula for chronic breathing therapy
Patients in the taVNS treatment group:taVNS treatment
The patient was treated with taVNS combined with the six-character Formula for slow breathing:taVNS combined with the Six-Character Formula for chronic breathing therapy
health control:none
Sponsors
Insitute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Study One: The Immediate Effect Characteristics of Slow Breathing with the Six-Character Formula on Cardiac Autonomic Nerve Function. Inclusion criteria for healthy volunteers: 1) Good sleep and denial of history or family history of neurological or mental system diseases; 2) No experience with acupuncture, neuroregulation or similar therapies; 3) High school education or above; 4) Right-handed; 5) No serious contraindications such as underlying diseases of the liver, kidneys, digestive system or hematopoietic system; 6) Age: 18-65 years old; 7) Sign informed consent; 8) No claustrophobia. Study Two: Characteristics of the Synergistic Effect of Six-Character Formula Slow Breathing on taVNS in Regulating Cardiac autonomic Nerve Function. Inclusion criteria for healthy volunteers: The same as in Study One. Study Three: Research on the Efficacy and Related Mechanisms of taVNS Combined with Six-Character Formula in the Treatment of Patients with Chronic Insomnia. Inclusion criteria for patients: 1) Meeting the diagnostic criteria for insomnia; 2) Deny a history of other neurological or mental system diseases or a family history; 3) Pittsburgh Sleep Scale score > 16 points; 4) Age: 18 to 65 years old; 5) The rest are the same as healthy subjects.
Exclusion criteria
Exclusion criteria: Study One: The Immediate Effect Characteristics of Slow Breathing with the Six-Character Formula on Cardiac Autonomic Nerve Function. Exclusion criteria for healthy volunteers: 1) A history of using psychotropic drugs in the last 3 months, including but not limited to antidepressants, sleeping pills, etc. 2) Those who have received acupuncture treatment recently; 3) Those who have recently received or have been practicing Tai Chi, yoga, breathing exercises and other exercises for a long time; 4) There is a stable record of angina pectoris or arrhythmia within one month; 5) Resting heart rate exceeds 120 beats per minute, systolic blood pressure is greater than 180mmHg, and diastolic blood pressure is greater than 100mmHg; 6) Pregnant, lactating or menstruating women, or those planning to become pregnant; 7) Those who have stayed up late or worked in shifts in the past two weeks; 8) People with missing ears or those allergic to ear clips; 9) Those who are allergic to electrocardiogram patches; Those who have a long-term habit of drinking tea or coffee, or who have consumed such beverages on the day before or on the day of the experiment. Study Two: Characteristics of the Synergistic Effect of Six-Character Formula Slow Breathing on taVNS in Regulating Cardiac autonomic Nerve Function. Exclusion criteria for healthy volunteers: The same as in Study One. Study Three: Research on the Efficacy and Related Mechanisms of taVNS Combined with Six-Character Formula in the Treatment of Patients with Chronic Insomnia. Exclusion criteria for patients: 1) Combined with other neurological and mental system diseases; 2) In the past three months, there has been a change in the use of psychotropic or potentially brain-stimulating medications (including but not limited to antidepressants and sleeping pills). 3) Secondary insomnia caused by physical illness or symptoms of mental disorder, etc. 4) Those who have received acupuncture treatment recently; 5) Those who have recently received or have been practicing Tai Chi, yoga, breathing exercises and other exercises for a long time; 6) People with missing ears or those allergic to ear clips; 7) People who are allergic to electrocardiogram patches; 8) The rest are the same as healthy subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram indicators;Functional Magnetic Resonance Imaging;Magnetic Resonance Spectrum;Insomnia Severity Index;Epworth Sleepiness Scale;Fatigue Severity scale;Hamilton's Depression Scale;Hamilton Anxiety Scale; | — |
Countries
China
Contacts
Public ContactZhao YaNan
Insitute of Acupuncture and Moxibustion,China Academy of Chinese Medical Science
Outcome results
None listed