Clinical trial NCT01956760: Effects of Acupuncture and Intradermal Acupuncture on Insomnia
Official title: A Randomized Controlled Clinical Trial to Evaluate Effectiveness of Acupuncture on Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: Kyunghee University
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. Acupuncture group will produce superior effect in the treatment of insomnia compared with control group.
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in ISI(Insomnia Severity Index) at 1 week
timeFrame: baseline and 1 week
Secondary outcomes:
measure: Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Baseline in STAI(State-Trait Anxiety Inventory) at 1 week
timeFrame: baseline and 1 week
measure: Change from Baseline in STAI(State-Trait Anxiety Inventory) at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Baseline in BDI(Beck Depression Inventory) at 1 week
timeFrame: baseline and 1 week
measure: Change from Baseline in BDI(Beck Depression Inventory) at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 1 week
timeFrame: baseline and 1 week
measure: Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Baseline in Sleep Logs at 1 week
timeFrame: baseline and 1 week
measure: Change from Baseline in Sleep Logs at 2 week
timeFrame: baseline and 2 weeks
measure: Change from Baseline in WHOQOL-Bref at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Auditory Verbal Learning Test at 1 week
timeFrame: baseline and 1 week
measure: Change from Baseline in Auditory Verbal Learning Test at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Digit Span Test at 1 week
timeFrame: baseline and 1 week
measure: Change from Digit Span Test at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Spectral analysis EEG at 1 week
timeFrame: baseline and 1 week
measure: Change from Spectral analysis EEG at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Auditory ERP at 1 week
timeFrame: baseline and 1 week
measure: Change from Auditory ERP at 2 weeks
timeFrame: baseline and 2 weeks
measure: Change from Heart Rate Variability at 1 week
timeFrame: baseline and 1 week
measure: Change from Heart Rate Variability at 2 weeks
timeFrame: baseline and 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG
Study officials:
affiliation: Kyunghee University
name: SUNYONG CHUNG, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.