Insomnia ChronicNCT03447587
Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia
A study testing Electroacupuncture in people with Insomnia Chronic, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Mar 2018to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, the Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Determining the Role of Acupuncture in the Modulation of Peripheral Oxidative Stress in Patients With Insomnia: A Randomized Placebo-Controlled Trial
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.
Read the 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.
- Conditions
- Insomnia Chronic
- Being tested
- Electroacupuncture, Sham acupuncture
- Keywords
- Randomized controlled trial, Sleep, Traditional Chinese medicine, Oxidative stress
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | Subjects will receive 4 weeks of acupuncture following with a semi-standardized protocol. Receives: Other: Electroacupuncture |
| Sham acupuncture group | Placebo comparator | Subjects will receive sham acupuncture with the same sterilization procedure as traditional acupuncture group. Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency (SE)
the sleep efficiency derived from 7 days sleep diary
Measured: Week 5
Secondary outcomes (15)
Sleep efficiency (SE)
the sleep efficiency derived from 7 days sleep diary
Measured: Baseline, week 9
Sleep onset latency (SOL)
the sleep onset latency derived from 7 days sleep diary
Measured: Baseline, week 5, week 9
Wake after sleep onset (WASO)
the Wake after sleep onset derived from 7 days sleep diary
Measured: Baseline, week 5, week 9
Total sleep time (TST)
the total sleep time derived from 7 days sleep diary
Measured: Baseline, week 5, week 9
Insomnia Severity Index (ISI)
the self reported severity of insomnia symptoms
Measured: Baseline, week 5, week 9
Hospital Anxiety and Depression (HADS)
the self reported anxiety and depression symptoms
Measured: Baseline, week 5, week 9
Short Form Six Dimension (SF6D)
the six dimension measure of health-related quality of life
Measured: Baseline, week 5, week 9
Actigraphy: Sleep onset latency (SOL)
The objective measure of sleep onset latency (SOL)
Measured: Baseline, week 5, week 9
Actigraphy: Wake after sleep onset (WASO)
The objective measure of wake after sleep onset (WASO)
Measured: Baseline, week 5, week 9
Actigraphy: Total sleep time (TST)
The objective measure of total sleep time (TST)
Measured: Baseline, week 5, week 9
Actigraphy: Sleep efficiency (SE)
The objective measure of sleep efficiency (SE)
Measured: Baseline, week 5, week 9
The level of MDA
The measure of oxidative stress parameters
Measured: Baseline, week 5
The activity of GPx
The measure of oxidative stress parameters
Measured: Baseline, week 5
The activity of PON
The measure of oxidative stress parameters
Measured: Baseline, week 5
The activity of ARE
The measure of oxidative stress parameters
Measured: Baseline, week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start15 Mar 2018
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to two groups in 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG Wing Fai, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447587
- Sponsor's protocol ID
- AcupOS
- Status last verified
- Apr 2021
- First submitted
- 17 Jan 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34321944
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Role of Acupuncture in the Modulation of Peripheral Oxidative Stress in Patients With Insomnia: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03447587
- Acronym / sponsor ID
- AcupOS
- Conditions
- Insomnia Chronic
- Keywords
- Randomized controlled trial, Sleep, Traditional Chinese medicine, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized to two groups in 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Other: ElectroacupunctureSubjects will receive 4 weeks of acupuncture following with a semi-standardized protocol. |
| Sham acupuncture group | Placebo comparator | Other: Sham acupunctureSubjects will receive sham acupuncture with the same sterilization procedure as traditional acupuncture group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureEach 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. | Other | Electroacupuncture |
| Sham acupunctureSubjects 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. | Other | Sham acupuncture group |
Primary outcome
Sleep efficiency (SE)
Time frame: Week 5
the sleep efficiency derived from 7 days sleep diary
15 secondary outcomes
Sleep efficiency (SE)
Time frame: Baseline, week 9
Sleep onset latency (SOL)
Time frame: Baseline, week 5, week 9
Wake after sleep onset (WASO)
Time frame: Baseline, week 5, week 9
Total sleep time (TST)
Time frame: Baseline, week 5, week 9
Insomnia Severity Index (ISI)
Time frame: Baseline, week 5, week 9
Hospital Anxiety and Depression (HADS)
Time frame: Baseline, week 5, week 9
Short Form Six Dimension (SF6D)
Time frame: Baseline, week 5, week 9
Actigraphy: Sleep onset latency (SOL)
Time frame: Baseline, week 5, week 9
Actigraphy: Wake after sleep onset (WASO)
Time frame: Baseline, week 5, week 9
Actigraphy: Total sleep time (TST)
Time frame: Baseline, week 5, week 9
Actigraphy: Sleep efficiency (SE)
Time frame: Baseline, week 5, week 9
The level of MDA
Time frame: Baseline, week 5
The activity of GPx
Time frame: Baseline, week 5
The activity of PON
Time frame: Baseline, week 5
The activity of ARE
Time frame: Baseline, week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 34321944Yeung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Insomnia Chronic, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (SE) (time frame: Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.