Sleep Initiation and Maintenance DisordersNCT04405427
A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia
A study testing head acupoints acupuncture and body acupoints acupuncture in people with Sleep Initiation and Maintenance Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- head acupoints acupuncture and body acupoints acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Aug 2020to 31 Aug 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 20~70 years,
- met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
- experienced insomnia at least three times a week for more than a month
- voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.
Who cannot join
- a pregnant or lactating woman
- the patient's insomnia is caused by mental disorders other than mild anxiety,
- the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
- the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
- the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
- the patient with cardiac pacemaker
- the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
- the patient has a history of sleep apnea
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Keelung
Tsai-Jean LEE, MD, 0978839269, Lee269@cgmh.org.tw
About this study
Official title: A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia: A Randomized Controlled Case Study
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia.
Read the detailed description
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled, and randomly assigned into two groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60 of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6, ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks.
The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.
The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).
- Being tested
- head acupoints acupuncture, body acupoints acupuncture
- Keywords
- acupuncture, primary insomnia
- 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.
head acupoints acupunctureProcedure or surgery
The participants will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and GB13 head acupoints aupunture treatment 3 times/ 1 week for 4 weeks.
body acupoints acupunctureProcedure or surgery
The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| head acupoints acupuncture | Experimental | Acupuncture treatment for 12 acupoints on both sides of the head Receives: Procedure: head acupoints acupuncture |
| body acupoints acupuncture | Active comparator | Acupuncture treatment for 12 acupoints on both sides of the body Receives: Procedure: body acupoints acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of The Epworth sleepiness scale (ESS)
The Epworth sleepiness scale (ESS) containing eight items that ask for self-reported disclosure of the expectation of "dozing" in a variety of situations. A sum of responses is calculated for a total score ranging from 0 to 24, higher scores mean a worse. outcome.
Measured: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Changes of The HADS(The Hospital Anxiety and Depression Scale)
The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, the scores ranged from 0 to 21 for anxiety and 0 to 21 for depression, higher scores mean a worse outcome.
Measured: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Changes of The PSQI(Pittsburgh Sleep Quality Index)
The 19 questions are combined into seven clinically-derived component scores, each weighted equally from 0-3. The seven component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
Measured: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Secondary outcomes (3)
HRV(Heart rate viability)
Frequency-domain analysis of heart rate variability (HRV), a noninvasive method, has been used to reflect cardiac autonomic nervous activity in humans. The high-frequency power (HF; 0.15-0.4 Hz) of HRV represents vagal (parasympathetic) control of heart rate. The low-frequency power (LF; 0.04- 0.15 Hz) of HRV is jointly contributed by both sympathetic and vagal nerves, whereas normalized LF (nLF) is regarded as the sympathetic modulation.
Measured: Baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion, an average of 1 year.
actigraphy (3-day)
Actigraphy provides objective estimates of sleep parameters including: SE(sleep efficiency), SA(sleep awakenings), TST(total sleep time)
Measured: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
sleep diary
The sleep diary provides daily subjective estimates of sleep parameters including: daytime nap, sleep aids intake, bedtime, sleep onset latency, frequency of nocturnal awakenings, awakenings duration, wake-up time, arising time, feeling upon arising (five-point scale) and sleep quality (five-point scale).
Measured: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start7 Aug 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Tsai-Jean, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405427
- Sponsor's protocol ID
- 201900496A3
- Status last verified
- May 2020
- First submitted
- 24 May 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be a research number representing the identity. This number will not display the name, identification number, and address. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia: A Randomized Controlled Case Study
- ClinicalTrials.gov ID
- NCT04405427
- Acronym / sponsor ID
- 201900496A3
- Keywords
- acupuncture, primary insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 28 May 2020 (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.
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia.
Detailed description
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled, and randomly assigned into two groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60 of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6, ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks.
The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.
The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| head acupoints acupuncture | Experimental | Procedure: head acupoints acupunctureAcupuncture treatment for 12 acupoints on both sides of the head |
| body acupoints acupuncture | Active comparator | Procedure: body acupoints acupunctureAcupuncture treatment for 12 acupoints on both sides of the body |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 20~70 years,
- met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
- experienced insomnia at least three times a week for more than a month
- voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.
Key exclusion criteria (8 listed)
- a pregnant or lactating woman
- the patient's insomnia is caused by mental disorders other than mild anxiety,
- the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
- the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
- the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
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 |
|---|---|---|
| head acupoints acupunctureThe participants will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and GB13 head acupoints aupunture treatment 3 times/ 1 week for 4 weeks. | Procedure or surgery | head acupoints acupuncture |
| body acupoints acupunctureThe participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks. | Procedure or surgery | body acupoints acupuncture |
Primary outcome
Changes of The Epworth sleepiness scale (ESS)
Time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
The Epworth sleepiness scale (ESS) containing eight items that ask for self-reported disclosure of the expectation of "dozing" in a variety of situations. A sum of responses is calculated for a total score ranging from 0 to 24, higher scores mean a worse. outcome.
Changes of The HADS(The Hospital Anxiety and Depression Scale)
Time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, the scores ranged from 0 to 21 for anxiety and 0 to 21 for depression, higher scores mean a worse outcome.
Changes of The PSQI(Pittsburgh Sleep Quality Index)
Time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
The 19 questions are combined into seven clinically-derived component scores, each weighted equally from 0-3. The seven component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
3 secondary outcomes
HRV(Heart rate viability)
Time frame: Baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion, an average of 1 year.
actigraphy (3-day)
Time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
sleep diary
Time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No. There will be a research number representing the identity. This number will not display the name, identification number, and address. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.
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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.
Lee Tsai-Jean, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head acupoints acupuncture and body acupoints acupuncture in people with Sleep Initiation and Maintenance Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Aug 2020. 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Tsai-Jean, MD (+886-933-750-627, cs8336@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of The Epworth sleepiness scale (ESS) (time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2020.