Status:
COMPLETED
Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Insomnia Chronic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A randomized controlled trial involving 140 subjects with (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) DSM-5 insomnia disorder after excluding those with other medical condit...
Detailed Description
Background: Insomnia is a very common complaint worldwide. Acupuncture is an alternative treatment for improving sleep quality. However, its efficacy and mechanism of action as a treatment for insomni...
Eligibility Criteria
Inclusion
- Hong Kong resident,
- ethnic Hong Kong Chinese aged 18-65,
- fulfilling diagnostic criteria of insomnia disorder using DSM-5 diagnostic criteria for Insomnia Disorder by Brief Insomnia Questionnaire,
- Insomnia Severity Index total score ≥11 at screening and baseline visits,
- willing to give informed consent and comply with the trial pr1otocol.
Exclusion
- any current or past major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders, organic mental disorder, schizophrenia or any other psychotic disorder as defined by DSM-IV criteria using the Structured Clinical Interview for DSM-IV (SCID);
- any current physical illnesses that contributes significantly to the subject's insomnia;
- pregnancy;
- a previous diagnosis of sleep apnea or periodic limb movement disorder (if subjects with symptoms suggestive of other sleep disorders, they will be referred to our psychiatrists for further assessment;
- a Home Single-Channel Nasal Pressure (HNP) screening with apnea-hypopnea index (AHI) \>5;
- at significant risk of suicide according to SCID;
- infection or abscess close to the site of the selected acupoints;
- valvular heart defects, bleeding disorders or taking anticoagulant drugs, use of any implanted electrical device such as pacemaker, defibrillator, brain and nerve stimulators, etc.;
- receiving acupuncture treatment in the past 6 months;
- taking herbal remedies, over-the-counter medication or psychotropic drugs that target insomnia within the two weeks prior to baseline
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03447587
Start Date
March 15 2018
End Date
September 20 2019
Last Update
April 29 2021
Active Locations (1)
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1
School of Nursing, the Hong Kong Polytechnic University
Hong Kong, Hong Kong