Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia
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|ClinicalTrials.gov Identifier: NCT03447587|
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Chronic||Other: Electroacupuncture Other: Sham acupuncture||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized to two groups in 1:1 ratio.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Determining the Role of Acupuncture in the Modulation of Peripheral Oxidative Stress in Patients With Insomnia: A Randomized Placebo-Controlled Trial|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 31, 2020|
Subjects will receive 4 weeks of acupuncture following with a semi-standardized protocol.
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.
- Sleep efficiency (SE) [ Time Frame: Week 5 ]the sleep efficiency derived from 7 days sleep diary
- Sleep efficiency (SE) [ Time Frame: Baseline, week 9 ]the sleep efficiency derived from 7 days sleep diary
- Sleep onset latency (SOL) [ Time Frame: Baseline, week 5, week 9 ]the sleep onset latency derived from 7 days sleep diary
- Wake after sleep onset (WASO) [ Time Frame: Baseline, week 5, week 9 ]the Wake after sleep onset derived from 7 days sleep diary
- Total sleep time (TST) [ Time Frame: Baseline, week 5, week 9 ]the total sleep time derived from 7 days sleep diary
- Insomnia Severity Index (ISI) [ Time Frame: Baseline, week 5, week 9 ]the self reported severity of insomnia symptoms
- Hospital Anxiety and Depression (HADS) [ Time Frame: Baseline, week 5, week 9 ]the self reported anxiety and depression symptoms
- Short Form Six Dimension (SF6D) [ Time Frame: Baseline, week 5, week 9 ]the six dimension measure of health-related quality of life
- Actigraphy: Sleep onset latency (SOL) [ Time Frame: Baseline, week 5, week 9 ]The objective measure of sleep onset latency (SOL)
- Actigraphy: Wake after sleep onset (WASO) [ Time Frame: Baseline, week 5, week 9 ]The objective measure of wake after sleep onset (WASO)
- Actigraphy: Total sleep time (TST) [ Time Frame: Baseline, week 5, week 9 ]The objective measure of total sleep time (TST)
- Actigraphy: Sleep efficiency (SE) [ Time Frame: Baseline, week 5, week 9 ]The objective measure of sleep efficiency (SE)
- The level of MDA [ Time Frame: Baseline, week 5 ]The measure of oxidative stress parameters
- The activity of GPx [ Time Frame: Baseline, week 5 ]The measure of oxidative stress parameters
- The activity of PON [ Time Frame: Baseline, week 5 ]The measure of oxidative stress parameters
- The activity of ARE [ Time Frame: Baseline, week 5 ]The measure of oxidative stress parameters