Heart Rate VariabilityNCT05745519
Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia
An observational study of Heart Rate Variability and Insomnia Chronic, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Discuss the objective assessment of patients with insomnia by pulse diagnosis, and measure by subjective questionnaire and physiological instruments. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability, Insomnia Chronic
- What is being tested?
- Pittsburgh sleep quality index (PSQI) and ANSWatch
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Discuss the objective assessment of patients with insomnia by pulse diagnosis, and measure by subjective questionnaire and physiological instruments.
Read the 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.
- Conditions
- Heart Rate Variability, Insomnia Chronic
- Being tested
- Pittsburgh sleep quality index (PSQI), ANSWatch
- Keywords
- Insomnia, Pulse, Heart rate variability
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ANSWatchDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pittsburgh sleep quality index (PSQI); Device: ANSWatch | |
| The control group | Healthy volunteer subjects aged 40-79 without insomnia. Receives: Other: Pittsburgh sleep quality index (PSQI); Device: ANSWatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index (PSQI)
Pittsburgh sleep quality index (PSQI)
Measured: 15 minutes
Secondary outcomes (5)
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: 15 minutes
Epworth Sleepiness Scale (ESS)
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
Measured: 15 minutes
The Green Climacteric Scale(GCS)
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
Measured: 15 minutes
General Sleep Disturbance Scale(GSDS)
Measure the patient's non-cognitive symptoms, family caregivers' perceived negative feelings of stress, caregivers' depression and sleep disturbance.
Measured: 15 minutes
Constitution in Chinese Medicine Questionnaire (CCMQ)
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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745519
- Sponsor's protocol ID
- 20220101
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT05745519
- Acronym / sponsor ID
- 20220101
- Conditions
- Heart Rate Variability, Insomnia Chronic
- Keywords
- Insomnia, Pulse, Heart rate variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | – | Other: Pittsburgh sleep quality index (PSQI), Device: ANSWatchAged 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 | – | Other: Pittsburgh sleep quality index (PSQI), Device: ANSWatchHealthy volunteer subjects aged 40-79 without insomnia. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | The control group, The experimental group |
| ANSWatchMeasure 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 | Device | The control group, The experimental group |
Primary outcome
Pittsburgh sleep quality index (PSQI)
Time frame: 15 minutes
Pittsburgh sleep quality index (PSQI)
5 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 15 minutes
Epworth Sleepiness Scale (ESS)
Time frame: 15 minutes
The Green Climacteric Scale(GCS)
Time frame: 15 minutes
General Sleep Disturbance Scale(GSDS)
Time frame: 15 minutes
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Variability and Insomnia Chronic, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index (PSQI) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.