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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05745519
Enrollment
72
Registered
2023-02-27
Start date
2022-01-01
Completion date
2022-12-31
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate Variability, Insomnia Chronic

Keywords

Insomnia, Pulse, Heart rate variability

Brief summary

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

Detailed 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.

Interventions

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.

DEVICEANSWatch

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

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh sleep quality index (PSQI)15 minutesPittsburgh sleep quality index (PSQI)

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS)15 minutesThe 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.
Epworth Sleepiness Scale (ESS)15 minutesThe 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
The Green Climacteric Scale(GCS)15 minutesThe 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
General Sleep Disturbance Scale(GSDS)15 minutesMeasure the patient's non-cognitive symptoms, family caregivers' perceived negative feelings of stress, caregivers' depression and sleep disturbance.
Constitution in Chinese Medicine Questionnaire (CCMQ)15 minutesThe 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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026