Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia

Study Overview
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Brief Summary
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Discuss the objective assessment of patients with insomnia by pulse diagnosis, and measure by subjective questionnaire and physiological instruments.

Detailed Description
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In Taiwan, insomnia is a prevalent illness. Clinical symptoms of sleep disturbances are rather typical now that the epidemic has taken hold. Pulse diagnosis is an important diagnostic method for insomnia in traditional Chinese medicine(TCM). TCM pulse diagnosis is not yet a widely used clinical diagnostic method for illnesses, nevertheless. Clinical use and teaching should benefit greatly if pulse diagnosis or learning can be made more objective or data-based.

Official Title
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Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia

Conditions
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Heart Rate Variability, Insomnia Chronic

Intervention / Treatment
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* Other: Pittsburgh sleep quality index (PSQI)
* Device: ANSWatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 40-60 years Complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning The score of sleep disorder on the Pittsburgh Sleep Quality Scale was more than 5 points Exclusion Criteria: History of psychiatric disorders History of sleep apnea or nocturnal myoclonus Center or neurodegenerative disease Cancer Melatonin or sleeping pills use in the past month

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The experimental group<br>Aged 40-79 years old, complained of insomnia symptoms in the past month, at least three times a week, for a month, such as: difficulty falling asleep, waking up in the middle of the night, waking up unable to fall asleep, waking up in the morning and still not getting enough sleep | Other: Pittsburgh sleep quality index (PSQI)<br>* The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general people.<br>Device: ANSWatch<br>* Measure eight physiological parameters including heartbeat, systolic blood pressure, diastolic blood pressure, heart rhythm variability HRV, low frequency component LF, high frequency component HF, LF/HF low frequency high frequency component ratio, and irregular heartbeat within five minutes<br>|
| The control group<br>Healthy volunteer subjects aged 40-79 without insomnia. | Other: Pittsburgh sleep quality index (PSQI)<br>* The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general people.<br>Device: ANSWatch<br>* Measure eight physiological parameters including heartbeat, systolic blood pressure, diastolic blood pressure, heart rhythm variability HRV, low frequency component LF, high frequency component HF, LF/HF low frequency high frequency component ratio, and irregular heartbeat within five minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index (PSQI) | Pittsburgh sleep quality index (PSQI) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that has been found to be a reliable instrument for detecting states of anxiety and depression in the setting of hospital outpatient clinic. | 15 minutes | 
| Epworth Sleepiness Scale (ESS) | The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities | 15 minutes | 
| The Green Climacteric Scale(GCS) | The Menopausal Symptom Scale will be used to measure menopausal symptoms in women. This scale was developed by Greene, with 21 items and four subscales: psychological, physiological, vasomotor, sexual dysfunction and other symptoms | 15 minutes | 
| General Sleep Disturbance Scale(GSDS) | Measure the patient's non-cognitive symptoms, family caregivers' perceived negative feelings of stress, caregivers' depression and sleep disturbance. | 15 minutes | 
| Constitution in Chinese Medicine Questionnaire (CCMQ) | The Chinese Medicine Constitutional Questionnaire (CCMQ) was developed by Wang et al. in Mainland China, according to the consensus of experts on types of BC TCM. It has 60 items measuring 9 types of BC: soft, lacking qi, lacking yang, lacking yin, moist sputum, moist heat, blood stasis, impaired qi and especially visceral organs. It was tested in the Beijing population to establish its facial validity. Its reliability and construction value have been proven in 2500 people from five different geographical districts in China | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Pulse, Heart rate variability