Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia
Condition: Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Electroacupuncture; Sham acupuncture
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
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
Keywords: Randomized controlled trial; Sleep; Traditional Chinese medicine; Oxidative stress