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

Completed

• Conditions: Insomnia Chronic; Heart Rate Variability
• Interventions: Other: Pittsburgh sleep quality index (PSQI); Device: ANSWatch

• Registration Number: NCT05745519
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The experimental group	Pittsburgh sleep quality index (PSQI)	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
The control group	Pittsburgh sleep quality index (PSQI)	Healthy volunteer subjects aged 40-79 without insomnia.
The control group	ANSWatch	Healthy volunteer subjects aged 40-79 without insomnia.
The experimental group	ANSWatch	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

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index (PSQI)	15 minutes	Pittsburgh sleep quality index (PSQI)

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	15 minutes	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
General Sleep Disturbance Scale(GSDS)	15 minutes	Measure 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 minutes	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
The Green Climacteric Scale(GCS)	15 minutes	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
Hospital Anxiety and Depression Scale (HADS)	15 minutes	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.

Trial Locations

Locations (1)

Ministry of Health and Welfare Tainan Hospital; 🇨🇳 Tainan, Taiwan