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

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05745519
Collaborator
(none)
72
1
12
6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Pittsburgh sleep quality index (PSQI)
  • Device: ANSWatch

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 Design

Study Type:
Observational
Actual Enrollment :
72 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
The experimental group

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)
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

The control group

Healthy volunteer subjects aged 40-79 without insomnia.

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

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh sleep quality index (PSQI) [15 minutes]

    Pittsburgh sleep quality index (PSQI)

Secondary Outcome Measures

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 79 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ministry of Health and Welfare Tainan Hospital Tainan Taiwan 700007

Sponsors and Collaborators

  • National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT05745519
Other Study ID Numbers:
  • 20220101
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Cheng-Kung University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2023