NCT03447587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

January 17, 2018

Last Update Submit

April 28, 2021

Conditions

Insomnia Chronic

Keywords

Randomized controlled trialSleepTraditional Chinese medicineOxidative stress

Outcome Measures

Primary Outcomes (1)

  • Sleep efficiency (SE)

    the sleep efficiency derived from 7 days sleep diary

    Week 5

Secondary Outcomes (15)

  • Sleep efficiency (SE)

    Baseline, week 9

  • Sleep onset latency (SOL)

    Baseline, week 5, week 9

  • Wake after sleep onset (WASO)

    Baseline, week 5, week 9

  • Total sleep time (TST)

    Baseline, week 5, week 9

  • Insomnia Severity Index (ISI)

    Baseline, week 5, week 9

  • +10 more secondary outcomes

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

Subjects will receive 4 weeks of acupuncture following with a semi-standardized protocol.

Other: Electroacupuncture

Sham acupuncture group

PLACEBO COMPARATOR

Subjects will receive sham acupuncture with the same sterilization procedure as traditional acupuncture group.

Other: Sham acupuncture

Interventions

ElectroacupunctureOTHER

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.

Electroacupuncture
Sham acupunctureOTHER

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.

Sham acupuncture group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Yeung WF, Yu BY, Yuen JW, Ho JYS, Chung KF, Zhang ZJ, Mak DSY, Suen LK, Ho LM. Semi-Individualized Acupuncture for Insomnia Disorder and Oxidative Stress: A Randomized, Double-Blind, Sham-Controlled Trial. Nat Sci Sleep. 2021 Jul 21;13:1195-1207. doi: 10.2147/NSS.S318874. eCollection 2021.

    PMID: 34321944DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized to two groups in 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 27, 2018

Study Start

March 15, 2018

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

HK(1)