Study Results
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.
UNKNOWN
40 participants
OBSERVATIONAL
2020-08-01
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Acupuncture and Intradermal Acupuncture on Insomnia
NCT01956760
Acupuncture for the Treatment of Insomnia
NCT00855140
Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia
NCT03447587
Acupuncture for Insomnia: a Randomized Controlled Trial
NCT02594670
Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia
NCT01891097
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.
The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
3. experienced insomnia at least three times a week for more than a month
4. voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.
Exclusion Criteria
2. the patient's insomnia is caused by mental disorders other than mild anxiety,
3. the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
4. the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
5. the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
6. the patient with cardiac pacemaker
7. the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
8. the patient has a history of sleep apnea
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201900516A3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.