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

NCT ID: NCT05745519

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Rate Variability Insomnia Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Pittsburgh sleep quality index (PSQI)

Intervention Type 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

Intervention Type 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

The control group

Healthy volunteer subjects aged 40-79 without insomnia.

Pittsburgh sleep quality index (PSQI)

Intervention Type 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

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ministry of Health and Welfare Tainan Hospital

Tainan City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20220101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Circadian Rhythm Monitoring Study
NCT07336654 NOT_YET_RECRUITING NA