InsomniaNCT01956760
Effects of Acupuncture and Intradermal Acupuncture on Insomnia
A study testing Acupuncture and intradermal acupuncture in people with Insomnia, run by Kyunghee University at 1 site in South Korea.
Trial summary
The aim of this clinical study is to observe the therapeutic effect of acupuncture and intradermal acupuncture in the treatment of insomnia Participants were randomized into the acupuncture group and control group. Both groups were treated 3 times in a week and assessed before and after the treatment. Hypothesis : 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Acupuncture and intradermal acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Oct 2014
- 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
- Male or female between the age of 18years and 65 years.
- Diagnosed as having Insomnia using Pittsburgh Sleep Quality Index(PSQI score>5).
- Have no problems with communication (for example, reading, writing, listening, speaking).
- Provided written informed consent.
Who cannot join
- Regular medication, Herbal medication or health functional food for treating insomnia
- Presence of major neuropsychiatric disorder (for example, mental retardation, psychosis and severe mood disorder)
- Presence of inflammatory skin disease on the acupuncture site
- Presence of bleeding disorders or takes anticoagulant
- Presence of severe physical diseases that may preclude the safe use of acupuncture
- Enrolled in another clinical study in the past 1 month
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial to Evaluate Effectiveness of Acupuncture on Insomnia
The aim of this clinical study is to observe the therapeutic effect of acupuncture and intradermal acupuncture in the treatment of insomnia
Participants were randomized into the acupuncture group and control group. Both groups were treated 3 times in a week and assessed before and after the treatment.
Hypothesis :
- Acupuncture group will produce superior effect in the treatment of insomnia compared with control group.
- Acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.
Read the detailed description
The acupuncture group is received acupuncture and intradermal acupuncture therapy at 5 acupoints on wrist and ankle. The control group is received same treatment at 5 sham points approximately 1cm lateral to the acupoints.
Except for the location of acupuncture points, all details of treatment are same between acupuncture group and control group. A certified practitioner treat both groups 3 times in a week. The acupuncture inserted into the skin for 20 minutes and the intradermal acupuncture inserted and fixed on the same points for 48~72 hours.
Severity of insomnia, anxiety, depression, quality of life, recognition, attention, and memory are assessed at the baseline, after the last treatment and at a week after the end of last treatment.
- Conditions
- Insomnia
- Being tested
- Acupuncture and intradermal acupuncture
- Keywords
- 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.
Acupuncture and intradermal acupunctureOther
The acupuncture was applied at 5 acupoints(HT7 Shenmen, PC6 Neiguan, SP6 Sanyinjiao, KI6 Zhaohai, BL62 Shenmai) 3 times in a week. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same acupoints, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture and intradermal acupuncture The acupuncture was applied at 5 acupoints(HT7 Shenmen, PC6 Neiguan, SP6 Sanyinjiao, KI6 Zhaohai, BL62 Shenmai) 3 times in a week. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same acupoints, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours Receives: Other: Acupuncture and intradermal acupuncture |
| Placebo Acupuncture | Placebo comparator | Placebo acupuncture and placebo intradermal acupuncture The acupuncture was applied 3 times in a week at 2 sham points on the wrist and 3 sham points on the ankle, approximately 1cm lateral to the acupoints. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same sham points, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in ISI(Insomnia Severity Index) at 1 week
Measured: baseline and 1 week
Secondary outcomes (20)
Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 1 week
Measured: baseline and 1 week
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Baseline in BDI(Beck Depression Inventory) at 1 week
Measured: baseline and 1 week
Change from Baseline in BDI(Beck Depression Inventory) at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 1 week
Measured: baseline and 1 week
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Baseline in Sleep Logs at 1 week
Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency
Measured: baseline and 1 week
Change from Baseline in Sleep Logs at 2 week
Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency
Follow-up
Measured: baseline and 2 weeks
Change from Baseline in WHOQOL-Bref at 2 weeks
Measured: baseline and 2 weeks
Change from Auditory Verbal Learning Test at 1 week
Measured: baseline and 1 week
Change from Baseline in Auditory Verbal Learning Test at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Digit Span Test at 1 week
Measured: baseline and 1 week
Change from Digit Span Test at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Spectral analysis EEG at 1 week
Measured: baseline and 1 week
Change from Spectral analysis EEG at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Auditory ERP at 1 week
Measured: baseline and 1 week
Change from Auditory ERP at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Change from Heart Rate Variability at 1 week
Measured: baseline and 1 week
Change from Heart Rate Variability at 2 weeks
Follow-up
Measured: baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
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 InsomniaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yong Chung, Kyunghee University
- Investigators
- SUNYONG CHUNG, ph.D, Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956760
- Sponsor's protocol ID
- KHNMC-OH-IRB 2011-015
- Status last verified
- Jan 2014
- First submitted
- 5 Sep 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Han KH, Kim SY, Chung SY. Effect of acupuncture on patients with insomnia: study protocol for a randomized controlled trial. Trials. 2014 Oct 23;15:403. doi: 10.1186/1745-6215-15-403.
PubMed 25342100
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Evaluate Effectiveness of Acupuncture on Insomnia
- ClinicalTrials.gov ID
- NCT01956760
- Acronym / sponsor ID
- KHNMC-OH-IRB 2011-015
- Conditions
- Insomnia
- Keywords
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kyunghee UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- 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 aim of this clinical study is to observe the therapeutic effect of acupuncture and intradermal acupuncture in the treatment of insomnia
Participants were randomized into the acupuncture group and control group. Both groups were treated 3 times in a week and assessed before and after the treatment.
Hypothesis :
- Acupuncture group will produce superior effect in the treatment of insomnia compared with control group.
- Acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.
Detailed description
The acupuncture group is received acupuncture and intradermal acupuncture therapy at 5 acupoints on wrist and ankle. The control group is received same treatment at 5 sham points approximately 1cm lateral to the acupoints.
Except for the location of acupuncture points, all details of treatment are same between acupuncture group and control group. A certified practitioner treat both groups 3 times in a week. The acupuncture inserted into the skin for 20 minutes and the intradermal acupuncture inserted and fixed on the same points for 48~72 hours.
Severity of insomnia, anxiety, depression, quality of life, recognition, attention, and memory are assessed at the baseline, after the last treatment and at a week after the end of last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture and intradermal acupunctureAcupuncture and intradermal acupuncture The acupuncture was applied at 5 acupoints(HT7 Shenmen, PC6 Neiguan, SP6 Sanyinjiao, KI6 Zhaohai, BL62 Shenmai) 3 times in a week. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same acupoints, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours |
| Placebo Acupuncture | Placebo comparator | –Placebo acupuncture and placebo intradermal acupuncture The acupuncture was applied 3 times in a week at 2 sham points on the wrist and 3 sham points on the ankle, approximately 1cm lateral to the acupoints. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same sham points, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female between the age of 18years and 65 years.
- Diagnosed as having Insomnia using Pittsburgh Sleep Quality Index(PSQI score>5).
- Have no problems with communication (for example, reading, writing, listening, speaking).
- Provided written informed consent.
Key exclusion criteria (7 listed)
- Regular medication, Herbal medication or health functional food for treating insomnia
- Presence of major neuropsychiatric disorder (for example, mental retardation, psychosis and severe mood disorder)
- Presence of inflammatory skin disease on the acupuncture site
- Presence of bleeding disorders or takes anticoagulant
- Presence of severe physical diseases that may preclude the safe use of acupuncture
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 |
|---|---|---|
| Acupuncture and intradermal acupunctureThe acupuncture was applied at 5 acupoints(HT7 Shenmen, PC6 Neiguan, SP6 Sanyinjiao, KI6 Zhaohai, BL62 Shenmai) 3 times in a week. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same acupoints, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours | Other | Acupuncture |
Primary outcome
Change from Baseline in ISI(Insomnia Severity Index) at 1 week
Time frame: baseline and 1 week
20 secondary outcomes
Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks
Time frame: baseline and 2 weeks
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 1 week
Time frame: baseline and 1 week
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 2 weeks
Time frame: baseline and 2 weeks
Change from Baseline in BDI(Beck Depression Inventory) at 1 week
Time frame: baseline and 1 week
Change from Baseline in BDI(Beck Depression Inventory) at 2 weeks
Time frame: baseline and 2 weeks
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 1 week
Time frame: baseline and 1 week
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 2 weeks
Time frame: baseline and 2 weeks
Change from Baseline in Sleep Logs at 1 week
Time frame: baseline and 1 week
Change from Baseline in Sleep Logs at 2 week
Time frame: baseline and 2 weeks
Change from Baseline in WHOQOL-Bref at 2 weeks
Time frame: baseline and 2 weeks
Change from Auditory Verbal Learning Test at 1 week
Time frame: baseline and 1 week
Change from Baseline in Auditory Verbal Learning Test at 2 weeks
Time frame: baseline and 2 weeks
Change from Digit Span Test at 1 week
Time frame: baseline and 1 week
Change from Digit Span Test at 2 weeks
Time frame: baseline and 2 weeks
Change from Spectral analysis EEG at 1 week
Time frame: baseline and 1 week
Change from Spectral analysis EEG at 2 weeks
Time frame: baseline and 2 weeks
Change from Auditory ERP at 1 week
Time frame: baseline and 1 week
Change from Auditory ERP at 2 weeks
Time frame: baseline and 2 weeks
Change from Heart Rate Variability at 1 week
Time frame: baseline and 1 week
Change from Heart Rate Variability at 2 weeks
Time frame: baseline and 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Derived from this study: PubMed 25342100Han KH, Kim SY, Chung SY. Effect of acupuncture on patients with insomnia: study protocol for a randomized controlled trial. Trials. 2014 Oct 23;15:403. doi: 10.1186/1745-6215-15-403.
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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.
SUNYONG CHUNG, ph.D principal investigator
Kyunghee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and intradermal acupuncture in people with Insomnia, run by Kyunghee University at 1 site in South Korea.
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 7 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 10 Jan 2014. 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 South Korea. 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?
Results are not available in the source record.
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?
Change from Baseline in ISI(Insomnia Severity Index) at 1 week (time frame: baseline and 1 week). 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 NCT01956760, 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 10 Jan 2014.