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Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia

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ClinicalTrials.gov Identifier: NCT03447587
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
YEUNG Wing Fai, The Hong Kong Polytechnic University

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 conditions, psychiatric disorders, and sleep disorders that may cause insomnia. The subjects will be randomly assigned to either acupuncture treatment or sham acupuncture (control group) in a 1:1 ratio. The acupuncture treatment group will receive acupuncture treatments using a semi-standardized protocol. In a similar way, the sham acupuncture control group will receive acupuncture using validated non-invasive sham acupuncture needles. Both subjective (the sleep questionnaire and sleep diary) and objective (actigraphy) outcome measures will be recorded at baseline and at 1- and 5-week post-treatment. Fasting blood samples will be taken on the morning of the assessments at these time points to measure the oxidative stress parameters, including the malondialdehyde (MDA) level, and the glutathione peroxidase (GPx), paraoxonase (PON), and arylesterase (ARE) activities. The primary outcome is sleep efficiency, measured using a 7-day sleep diary and the oxidative stress parameters at 1-week post-treatment.

Condition or disease Intervention/treatment Phase
Insomnia Chronic Other: Electroacupuncture Other: Sham acupuncture Not Applicable

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 insomnia requires further investigation. Acupuncture may attenuate oxidative stress which is thought to be an important pathophysiological factor in insomnia.

Aims: To evaluate the safety and efficacy of a semi-individualized acupuncture treatment in improving sleep, and to examine its effects on oxidative stress parameters in subjects with primary insomnia disorder.

Methods: This will be a randomized controlled trial involving 140 subjects with DSM-5 insomnia disorder after excluding those with other medical conditions, psychiatric disorders, and sleep disorders that may cause insomnia. The subjects will be randomly assigned to either acupuncture treatment or sham acupuncture (control group) in a 1:1 ratio. The acupuncture treatment group will receive acupuncture treatments using a semi-standardized protocol. In a similar way, the sham acupuncture control group will receive acupuncture using validated non-invasive sham acupuncture needles. Both subjective (the sleep questionnaire and sleep diary) and objective (actigraphy) outcome measures will be recorded at baseline and at 1- and 5-week post-treatment. Fasting blood samples will be taken on the morning of the assessments at these time points to measure the oxidative stress parameters, including the malondialdehyde (MDA) level, and the glutathione peroxidase (GPx), paraoxonase (PON), and arylesterase (ARE) activities. The primary outcome is sleep efficiency, measured using a 7-day sleep diary and the oxidative stress parameters at 1-week post-treatment.

Data analysis: Changes in the sleep and oxidative stress outcome measures will be compared between groups by using a mixed-effects model at each time point. Correlations between sleep parameters and oxidative stress parameters will be examined using a Pearson correlation. Mediation analysis will be performed to explore the possible mediating effect of oxidative stress factors on sleep.

Significance: The relationship between oxidative stress and insomnia severity has been under-researched. To the best of our knowledge, there has thus far been no study on the effect of acupuncture on oxidative stress in subjects with insomnia disorder. The present study will not only provide high-quality evidence of the efficacy of acupuncture as a treatment for insomnia, but also of the associated changes in oxidative stress parameters. It will guide future studies on the treatment mechanism and pathophysiology of insomnia.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized to two groups in 1:1 ratio.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining the Role of Acupuncture in the Modulation of Peripheral Oxidative Stress in Patients With Insomnia: A Randomized Placebo-Controlled Trial
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Electroacupuncture
Subjects will receive 4 weeks of acupuncture following with a semi-standardized protocol.
Other: Electroacupuncture
Each subject will be treated with predefined acupoints including bilateral Ear-Shenmen, Touwei (ST8), Sishencong (EX-HN1), and unilateral Yintang (EXHN3) and Baihui (GV20) on the head (total 8 needles). Subject's current symptoms will be ascertained using a Traditional Chinese Medicine symptom checklist and eight additional acupoints will therefore be selected and needled based on their clinical judgements. The acupuncture treatment will consistent of two sessions per week (30 minutes) for 4 consecutive weeks.

Placebo Comparator: Sham acupuncture group
Subjects will receive sham acupuncture with the same sterilization procedure as traditional acupuncture group.
Other: Sham acupuncture
Subjects will be treated at 1 cm posteriorly and laterally adjacent to the same acupoints as the traditional acupuncture group using validated non-invasive sham needles. Subjects will also be assessed with Traditional Chinese Medicine checklist. The acupuncturist, setting, treatment frequency, and duration of the treatment course will be the same as in the traditional acupuncture group.




Primary Outcome Measures :
  1. Sleep efficiency (SE) [ Time Frame: Week 5 ]
    the sleep efficiency derived from 7 days sleep diary


Secondary Outcome Measures :
  1. Sleep efficiency (SE) [ Time Frame: Baseline, week 9 ]
    the sleep efficiency derived from 7 days sleep diary

  2. Sleep onset latency (SOL) [ Time Frame: Baseline, week 5, week 9 ]
    the sleep onset latency derived from 7 days sleep diary

  3. Wake after sleep onset (WASO) [ Time Frame: Baseline, week 5, week 9 ]
    the Wake after sleep onset derived from 7 days sleep diary

  4. Total sleep time (TST) [ Time Frame: Baseline, week 5, week 9 ]
    the total sleep time derived from 7 days sleep diary

  5. Insomnia Severity Index (ISI) [ Time Frame: Baseline, week 5, week 9 ]
    the self reported severity of insomnia symptoms

  6. Hospital Anxiety and Depression (HADS) [ Time Frame: Baseline, week 5, week 9 ]
    the self reported anxiety and depression symptoms

  7. Short Form Six Dimension (SF6D) [ Time Frame: Baseline, week 5, week 9 ]
    the six dimension measure of health-related quality of life

  8. Actigraphy: Sleep onset latency (SOL) [ Time Frame: Baseline, week 5, week 9 ]
    The objective measure of sleep onset latency (SOL)

  9. Actigraphy: Wake after sleep onset (WASO) [ Time Frame: Baseline, week 5, week 9 ]
    The objective measure of wake after sleep onset (WASO)

  10. Actigraphy: Total sleep time (TST) [ Time Frame: Baseline, week 5, week 9 ]
    The objective measure of total sleep time (TST)

  11. Actigraphy: Sleep efficiency (SE) [ Time Frame: Baseline, week 5, week 9 ]
    The objective measure of sleep efficiency (SE)

  12. The level of MDA [ Time Frame: Baseline, week 5 ]
    The measure of oxidative stress parameters

  13. The activity of GPx [ Time Frame: Baseline, week 5 ]
    The measure of oxidative stress parameters

  14. The activity of PON [ Time Frame: Baseline, week 5 ]
    The measure of oxidative stress parameters

  15. The activity of ARE [ Time Frame: Baseline, week 5 ]
    The measure of oxidative stress parameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 ≥15 at screening and baseline visits,
  • willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447587


Locations
Hong Kong
School of Nursing, the Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong
Contact: Wing-Fai Yeung       jerry-wf.yeung@polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University

Responsible Party: YEUNG Wing Fai, Assistant professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03447587     History of Changes
Other Study ID Numbers: AcupOS
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by YEUNG Wing Fai, The Hong Kong Polytechnic University:
Randomized controlled trial
Sleep
Traditional Chinese medicine
Oxidative stress

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders