Chronic insomnia
Conditions
Interventions
EECP:The counterpulsation pressure was 0.025Mpa, 45min/ time, 5 times/week, a total of 35 times
shamEECP :The counterpulsation pressure was 0.010Mpa, 45min/ time, 5 times/week, a total of 35 times
Sponsors
The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)aged 18-75 years old; 2) patients with chronic insomnia meeting the ICSD-3 criteria [A. nocturnal sleep disturbances (difficulty falling asleep or staying asleep or waking up early); B. related daytime symptoms such as fatigue and memory loss; C. at least 3 times per week; D. for more than 3 months]; 3) Pittsburgh Sleep Quality Index (PSQI) score > 5; 4) no EECP treatment in the past 6 months; 5) no use of hypnotics in the past 6 months; 6) Signing informed consent.
Exclusion criteria
Exclusion criteria: 1) patients with mental illness, caffeine, alcohol, or drug addiction, or Hospital Anxiety and Depression Scale score >=11; 2) those that affect circadian rhythm (e.g., shift work or day/night schedule changes); 3) patients with diagnosed serious or systemic diseases (e.g., hyperthyroidism, chronic liver disease, chronic kidney disease) that affect sleep; 4) severe pain or illness affecting sleep; 5) Unable to comply with treatment, questionnaire or study protocol; 6) participated in other research projects in the past 6 months; 7) Contraindications to enhanced external counterpulsation [moderate to severe aortic insufficiency, dissecting aneurysm, significant pulmonary hypertension, various bleeding diseases or bleeding tendency, or use of anticoagulants, INR > 2.0, various valvular heart disease or congenital heart disease with cardiac insufficiency, active phlebitis, venous thrombosis, infection of the counterpulsation limb; Uncontrolled hypertension (>=170/110 MMHG), uncontrolled arrhythmia, including frequent premature beats, severe left heart failure, severe left heart failure, severe arterial occlusive disease of the lower extremity, pregnancy].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of PSQI score between the experimental group and the control group after 7 weeks of intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in peak oxygen uptake in the experimental group compared with the control group after intervention;Change in vascular endothelial function in the experimental group compared with the control group after intervention;Change in total sleep time in the experimental group compared with the control group after intervention;Change in sleep efficiency in the experimental group compared with the control group after intervention;Change in awakenings in the experimental group compared with the control group after intervention;Change in sleep latency in the experimental group compared with the control group after intervention;Change in quality of life score in the experimental group compared with the control group after intervention;Change in Hospital Anxiety and Depression scale score in the experimental group compared with the control group after intervention;Change in NF-?B in the experimental group compared with the control group after intervention;Change in cryptochrome 1 in the experimental group compared with the control group after intervention;Change in melatonin in the experimental group compared with the control group after intervention;Change in 5-hydroxytryptamine in the experimental group compared with the control group after intervention;Change in tumor necrosis factor-a in the experimental group compared with the control group after intervention;Change in vascular endothelial growth factor (VEGFA) in the experimental group compared with the control group after intervention;Change in vascular endothelial growth factor receptor (VEGFR) in the experimental group compared with the control group after intervention;Change in cryptochrome 2 in the experimental group compared with the control group after intervention;Changes in oscillatory shear index compared with rest and control;Changes in mean arterial pressure compared with control;Changes in cerebral blood flow compared control;Changes in wall shear stress compared with rest and control; | — |
Countries
China
Contacts
Public ContactXu Xiuli
The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
Outcome results
None listed