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The Study of the Relationship of Insomnia in the Traditional Chinese Medicine and Western Medicine at Local Clinic

23 mei 2017 bijgewerkt door: Ching-Liang Hsieh, China Medical University Hospital

Insomnia is one of the most main diseases of civilization in the world, which chronic insomnia is up to 30% in Taiwan under the latest statistics and a common disease which appears to sleep difficultly, sleep interrupted, wake up early or wake up still tired. Long-term persistence of these symptoms will lead to the occurrence of mental illness and then affect people's emotional behavior and cognitive memory, showing that insomnia is an important modern health issues. Recently, "individual response patterns" was proposed by modern medicine. This thinking process and spirit seems to be compatible with the traditional Chinese medicine (TCM) therapy of "Differential Treatment". The purpose of this study, the Athens Insomnia Scale (AIS), commonly used to quickly screen for insomnia patients and the evaluation of Western medicine efficacy in Western medicine clinic, and investigation of Syndrome Type of TCM to find out whether with Syndrome Type of TCM and AIS in the associated factors, and confirm the necessity and importance of Syndrome Type of TCM, for future reference and basis for the development of integrated medicine.

In the cross-section study with an interview on survey, sampling Miaoli County an Chinese medicine clinic, in line with standard sampling of 200 patients with insomnia were recruited. The questionnaires contained two instruments including Athens Insomnia Scale (AIS), and Syndrome Type of TCM questionnaire. Cross-table, chi-square test, variance analysis and Pearson product-moment correlation was used to find the relation.

Studie Overzicht

Toestand

Onbekend

Conditie

Gedetailleerde beschrijving

Insomnia is a common sleep disturbance, there were more than a quarter of people with sleep disorders, the prevalence with more and higher, seriously affecting the health and quality of life. The Athens Insomnia Scale (referred to as AIS) can help physicians more accurately diagnose and understand the state of insomnia patients. The purpose of this study was investigated the correlation among the disease status, treatment and AIS assessment, hoping enough traditional Chinese physician and Western physician's clinical reference. Methods: This study used the cross-sectional questionnaire survey with the convenience sampling method. Screened 200 patients according to the diagnostic criteria for insomnia and conducted a survey from the local clinic at Miaoli County.

Studietype

Observationeel

Inschrijving (Verwacht)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Miaoli County, Taiwan, 350
        • Werving
        • Zhunan Ho-Te Chinese medicine clinic
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

an Chinese medicine clinic at Miaoli County

Beschrijving

Inclusion Criteria:

  • Compliance with the International Statistical Classification of Diseases and Related Health Problems (ICD)-10 and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and other international standards in the diagnosis of non-organic insomnia criteria to determine the main diagnosis and secondary diagnosis of insomnia: A. Complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically nonrestorative or poor in quality. B. Any sleep difficulty at least three times a week and during the period of the last month. C. Over concerns or worries about sleep. D. The night time sleep difficulty is related to daytime impairment: mood disturbance or social and vocational dysfunction
  • Cooperation with physician voluntarily, communication with physician normally

Exclusion Criteria:

  • Teenagers and babies
  • Insomnia associated with other sleep disorders most commonly includes sleep related breathing disorders (e.g.,obstructive sleep apnea), movement disorders (e.g.,restless legs or periodic limb movements during sleep) or circadian rhythm sleep disorders;
  • Insomnia due to medical or psychiatric disorders (Schizophrenia, paranoia, affective psychosis, bipolar disorder, depression, organic psychosis like brain injury, epilepsy, dementia and so on), or to drug/substance (comorbid insomnia); and
  • Primary insomnias including psychophysiological, idiopathic, and paradoxical insomnias.
  • Lack of intelligence or other reasons it is difficult to correctly fill the questionnaire

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Insomnia
those with unsatisfactory sleep quantity and/or quality (difficulty with sleep induction, awakenings during the night, early morning awakening, total sleep time, and overall quality of sleep), complaint of a minimum frequency (at least three times a week) and duration (1 month), marked distress caused by the sleep problem and/or interference with ordinary activities of daily living

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Questionnaires and Data analysis
Tijdsspanne: Patients were estimated any sleep difficulty during the period of last 4 weeks and then finished record about 15-20 minutes. A copy was done after 2 weeks. From date of randomization until the date of final documented progression, assessed 2 months.
Scores for each sleep dimension on the AIS questionnaire compared to Syndrome Type of TCM questionnaire. The AIS questionnaire contains 8 items which are rated on 0-3 scale ("0" means "no problem", "1" means "mild problem", "2" means "marked problem", "3" means "severe problem"). For each dimension, item scores are coded, summed, and transformed on to a scale from 0 (best sleep) to 24 (worst sleep) as an individual's sleep outcome. Syndrome Type of TCM questionnaire contains 6 patterns: pattern of yin deficiency with effulgent fire, pattern of deficiency of both heart and spleen, pattern of liver depression transforming into fire, pattern of phlegm-heat harassing internally, pattern of heart and gallbladder qi insufficiency, the other patterns as well and case numbers are counted as an TCM pattern's outcome. Finally, study the distribution law of insomnia's TCM pattern identification and relative factors of AIS.
Patients were estimated any sleep difficulty during the period of last 4 weeks and then finished record about 15-20 minutes. A copy was done after 2 weeks. From date of randomization until the date of final documented progression, assessed 2 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Ching-Liang Hsieh, China Medical University Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 mei 2017

Primaire voltooiing (Verwacht)

4 mei 2018

Studie voltooiing (Verwacht)

4 mei 2018

Studieregistratiedata

Eerst ingediend

18 mei 2017

Eerst ingediend dat voldeed aan de QC-criteria

23 mei 2017

Eerst geplaatst (Werkelijk)

24 mei 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 mei 2017

Laatste update ingediend die voldeed aan QC-criteria

23 mei 2017

Laatst geverifieerd

1 mei 2017

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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