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

Heart Rate Variability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05745519
• Other study ID #: 20220101
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Rate Variability
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Pittsburgh sleep quality index (PSQI)
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.

Device:
• ANSWatch
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

Locations

Country	Name	City	State
Taiwan	Ministry of Health and Welfare Tainan Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh sleep quality index (PSQI)	Pittsburgh sleep quality index (PSQI)	15 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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