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

NCT05745519 | Completed

• 1 other identifier: 20220101
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Rate Variability; Insomnia Chronic

Keywords

Insomnia; Pulse; Heart rate variability

Outcome Measures

Primary Outcomes (1)

• Pittsburgh sleep quality index (PSQI)

  Pittsburgh sleep quality index (PSQI)

  15 minutes

Secondary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS)

  15 minutes

• Epworth Sleepiness Scale (ESS)

  15 minutes

• The Green Climacteric Scale(GCS)

  15 minutes

• General Sleep Disturbance Scale(GSDS)

  15 minutes

• Constitution in Chinese Medicine Questionnaire (CCMQ)

  15 minutes

Study Arms (2)

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); Device: ANSWatch

The control group

Healthy volunteer subjects aged 40-79 without insomnia.

Other: Pittsburgh sleep quality index (PSQI); Device: ANSWatch

Interventions

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.

The control group; The experimental group

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

The control group; The experimental group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In the experimental group, select subjects who meet the following conditions: aged 40-79 years, who complained of insomnia symptoms in the past month, at least three times a week for one month, such as: difficulty falling asleep, waking up in the middle of the night, unable to wake up Falling asleep, waking up in the morning still feeling sleepy. Control group: healthy voluntary subjects aged 40-79 without insomnia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Ministry of Health and Welfare Tainan Hospital

Tainan, 700007, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

TW (1)