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Completed

NCT Number: NCT05745519

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

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

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Key information

Conditions

Heart Rate Variability Dyssomnias Insomnia Chronic Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ministry of Health and Welfare Tainan Hospital

Tainan, 700007, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pittsburgh Sleep Quality Index (PSQI)

Other

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.

ANSWatch

Device

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

Primary outcomes

  1. Pittsburgh sleep quality index (PSQI)

    Time frame: 15 minutes

    Pittsburgh sleep quality index (PSQI)

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2023
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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