Chronic Insomnia Disorder
Conditions
Interventions
Comfort needle group:Comfort Acupuncture Combined with Usual Tapering Group
Control group:Usual tapering group
Treatment group:Acupuncture Combined with Usual Tapering Group
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine;Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years inclusive with no gender restrictions;2.Meeting the chronic insomnia diagnostic criteria as defined in the ICSD-3TR;3.Insomnia Severity Index (ISI) score of =21 while on BZRAs medication;4.Undergoing benzodiazepine receptor agonist treatment for chronic insomnia for more than 6 months with medication adherence over 50% and a frequency of at least 3 nights per week in the past 2 weeks;5.Using BZRAs medications recommended by the "Chinese Guideline for the Diagnosis and Treatment of Adult Insomnia (2023 Edition)" including benzodiazepines non-benzodiazepines and novel benzodiazepine receptor agonists with each dosage not exceeding the maximum recommended in the guideline;6.Self-reported history of at least one unsuccessful attempt to discontinue BZRAs;7.A personal desire to reduce BZRAs medication;8.No acupuncture treatment received in any form within the past 3 months;9.Willingness to participate in the study comply with the protocol requirements and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Apnea-Hypopnea Index (AHI) of 15 or more events per hour as detected by polysomnography (PSG) and/or periodic limb movement index with arousal of 15 or more events per hour and/or evidence of REM sleep without atonia and/or dream enactment behaviors.2. Shift work schedule or travel across more than two time zones during the two weeks prior to screening or at any time during the study period.3.Use of anxiolytics antidepressants antipsychotics melatonin or melatonin receptor agonists during the two weeks prior to screening or at any time during the study period.4History of alcohol or substance use disorder within the past year.5.History of severe psychiatric disorders (e.g. bipolar disorder major depression).6.Severe cardiovascular hepatic renal hematologic or respiratory diseases; uncontrolled infectious diseases.7.Needle phobia or conditions such as infection inflammation scarring or injury near selected acupuncture points that would prevent acupuncture therapy.8.Pregnant or breastfeeding women.9.Any condition that the investigator deems unsuitable for the study.10.Participation in any interventional clinical trial within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of drug withdrawal after 6 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionaire-9;Consensus sleep diary;Pittsburgh Sleep Quality Index;Epworth Sleepiness Scale;Generalized Anxiety Disorder 7-item;Acupuncture Expectancy Scale;the tapering rate of BZRAs medications;Fatigue Severity Scale;Objective sleep architecture metrics;blind assessment;Insomnia Severity Index;Benzodiazepine Hypnotics Withdrawal Symptom Scale;Visual Analogue Scale; | — |
Countries
China
Contacts
Public ContactChen Yun-fei
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine.Shanghai University of Traditional Chinese Medicine
Outcome results
None listed