Back to resultsAuricular Acupuncture for Primary Insomnia (AAPI)
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
auricular acupuncture(AA)
placebo AA
Eszopiclone
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring primary insomnia, auricular acupuncture
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnosis of PI according to DSM-5;
- Aged 18-64 (including 18 and 64);
- Provided a signed written consent form.
Exclusion Criteria:
- The patient has somatic disease like severe respiratory, circulatory, endocrine system disease and hepatic/renal insufficiency;
- The patient suffers from moderate / major depression (BDI score ≧ 8 points), moderate / severe anxiety disorder (SAS score ≧ 61 points) or any other serious mental disease;
- The patient who abuse drug alcohol or substance;
- The patient suffers from dementia or any other severe cognitive impairment;
- The patient is in pregnancy or lactation period;
- Patient who is a night worker or stick to irregular sleep pattern, and can't or don't want to terminate this kind of work mode;
- The patient has history of suicide or suicidal tendency;
- The patient is allergic to Eszopiclone or any other sedative-hypnotic drugs;
- The patient who has taken psychiatric, hypnotic or antihistamine drugs during the last 4 weeks before baseline, however, the patient who use the prescription or nonprescription hypnotic drugs no more than twice a week can be recruited as soon as drug withdrawal;
- The patient who is receiving ongoing psychological treatment;
- The patient who has obstructive sleep apnea, restless leg syndrome, sleep rhythm disorders, parasomnias, etc.
Sites / Locations
- Chengdu university of Traditonal Chinese Medcine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
auricular acupuncture(AA) & Eszopiclone
placebo AA & Eszopiclone
Arm Description
The disposable Seirin Pyonex Needle will be chosen as AA material to attach every 3 days for 4 weeks, meanwhile, oral Eszopiclone 1 piece (3mg) will be applied 15 minutes before going to sleep everyday for 4 weeks. The manufacturer of disposable Seirin Pyonex Needles is Seirin Corporation, a Japanese company.
The disposable Pyonex Zero Needle, a non-invasive material will be chosen as placebo AA, with auricular acupoints have no certain effect on PI. Additionally, 1 piece (3mg) Eszopiclone will be administrated to participants 15 minutes before going to sleep everyday for 4 weeks.
Outcomes
Primary Outcome Measures
Sleep Onset Latency (SOL)
SOL is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to the time it takes to fall asleep, starting from the moment of having intention to fall asleep, stopping at the moment of getting a 5-minute continuous sleep.
Wake After Sleep Onset (WASO)
WASO is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to the total time of awakening which from the initial sleep onset to the last awakening.
Secondary Outcome Measures
Pittsburgh Sleep Quality Index(PSQI)
Insomnia Severity Index (ISI)
Beck Depression Inventory (BDI)
State-Trait Anxiety Inventory (STAI)
Self-rating Anxiety Scale (SAS)
The Epworth Sleeping Scale (ESS)
Flinders Fatigue Scale (FFS)
The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)
Total Sleep Time (TST)
TST is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to actually time slept, it's the amount of time from the initial sleep to final awakening, excluding the awake time.
Sleep Efficiency (SE)
SE is one of the sleep parameters mainly measured by actigraphy and sleep diaries, sleep efficiency percentage = [total sleep time/total time in bed] ×100%.
Number of awakenings (nWAK)
Obtained by actigraphy and sleep diaries, it's the number of awakening times from the initial sleep onset to the end of sleep.
Full Information
NCT ID
NCT02087488
First Posted
February 28, 2014
Last Updated
February 13, 2020
Sponsor
Chengdu University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02087488
Brief Title
Auricular Acupuncture for Primary Insomnia
Acronym
AAPI
Official Title
Auricular Acupuncture for Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .
Detailed Description
Investigators will conduct a 2-year clinical trial on auricular acupuncture (AA) for primary insomnia (PI), which is a double-blind (patient-blind and assessor-blind) RCT. 288 patients will be randomly assigned into 2 groups: the treatment group (Group A) and the control group (Group B). Group A will be treated with AA plus oral Eszopiclone, while Group B will be treated with sham AA plus oral Eszopiclone. All patients will receive a continuous 4-week treatment and 28-week follow-up. The data will be analyzed by the third party who is not clear about allocation and treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
primary insomnia, auricular acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
auricular acupuncture(AA) & Eszopiclone
Arm Type
Experimental
Arm Description
The disposable Seirin Pyonex Needle will be chosen as AA material to attach every 3 days for 4 weeks, meanwhile, oral Eszopiclone 1 piece (3mg) will be applied 15 minutes before going to sleep everyday for 4 weeks. The manufacturer of disposable Seirin Pyonex Needles is Seirin Corporation, a Japanese company.
Arm Title
placebo AA & Eszopiclone
Arm Type
Placebo Comparator
Arm Description
The disposable Pyonex Zero Needle, a non-invasive material will be chosen as placebo AA, with auricular acupoints have no certain effect on PI. Additionally, 1 piece (3mg) Eszopiclone will be administrated to participants 15 minutes before going to sleep everyday for 4 weeks.
Intervention Type
Other
Intervention Name(s)
auricular acupuncture(AA)
Intervention Description
Auricular acupoints: Shenmen (TF4), Heart (CO15), Subcortex (AT4), modifying points according to different patterns.
Auricular attachment material: disposable Seirin Pyonex Needle Seirin Pyonex Needle manufacturer: Seirin Corporation, a Japanese company. Medical Device Certification number: No. 15500BZZ00806000.
Treatment frequency: every 3 days.
Duration: 4 weeks.
Intervention Type
Other
Intervention Name(s)
placebo AA
Intervention Description
Auricular acupoints: Wrist (SF1), Clavicle (SF6), Shoulder (SF4、5), Tooth (LO1), Tonsil (LO7, 8, 9).
Auricular attachment material: the disposable Pyonex Zero Needle Pyonex Zero Needle manufacturer: Seirin Corporation, a Japanese company.
Treatment frequency: every 3 days.
Duration: 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta or Estorra
Intervention Description
Dosage form: tablet.
Dosage: 1 piece (3mg).
Drug manufacturer: Kanghong pharmaceutical limited liability company, Chengdu.
Production license: NO. H20100074 approved by the state.
Treatment frequency: 15 mins before going to bed everyday.
Duration: 4 weeks.
Primary Outcome Measure Information:
Title
Sleep Onset Latency (SOL)
Description
SOL is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to the time it takes to fall asleep, starting from the moment of having intention to fall asleep, stopping at the moment of getting a 5-minute continuous sleep.
Time Frame
Change from baseline in SOL at 4 weeks
Title
Wake After Sleep Onset (WASO)
Description
WASO is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to the total time of awakening which from the initial sleep onset to the last awakening.
Time Frame
Change from baseline in WASO at 4 weeks
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index(PSQI)
Time Frame
Change from baseline in PSQI at 4 weeks
Title
Insomnia Severity Index (ISI)
Time Frame
Change from baseline in ISI at 4 weeks
Title
Beck Depression Inventory (BDI)
Time Frame
Change from baseline in BDI at 4 weeks
Title
State-Trait Anxiety Inventory (STAI)
Time Frame
Change from baseline in STAI at 4 weeks
Title
Self-rating Anxiety Scale (SAS)
Time Frame
Change from baseline in SAS at 4 weeks
Title
The Epworth Sleeping Scale (ESS)
Time Frame
Change from baseline in ESS at 4 weeks
Title
Flinders Fatigue Scale (FFS)
Time Frame
Change from baseline in FFS at 4 weeks
Title
The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)
Time Frame
Change from baseline in SF-36 at 4 weeks
Title
Total Sleep Time (TST)
Description
TST is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to actually time slept, it's the amount of time from the initial sleep to final awakening, excluding the awake time.
Time Frame
Change from baseline in TST at 4 weeks
Title
Sleep Efficiency (SE)
Description
SE is one of the sleep parameters mainly measured by actigraphy and sleep diaries, sleep efficiency percentage = [total sleep time/total time in bed] ×100%.
Time Frame
Change from baseline in SE at 4 weeks
Title
Number of awakenings (nWAK)
Description
Obtained by actigraphy and sleep diaries, it's the number of awakening times from the initial sleep onset to the end of sleep.
Time Frame
Change from baseline in nWAK at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the diagnosis of PI according to DSM-5;
Aged 18-64 (including 18 and 64);
Provided a signed written consent form.
Exclusion Criteria:
The patient has somatic disease like severe respiratory, circulatory, endocrine system disease and hepatic/renal insufficiency;
The patient suffers from moderate / major depression (BDI score ≧ 8 points), moderate / severe anxiety disorder (SAS score ≧ 61 points) or any other serious mental disease;
The patient who abuse drug alcohol or substance;
The patient suffers from dementia or any other severe cognitive impairment;
The patient is in pregnancy or lactation period;
Patient who is a night worker or stick to irregular sleep pattern, and can't or don't want to terminate this kind of work mode;
The patient has history of suicide or suicidal tendency;
The patient is allergic to Eszopiclone or any other sedative-hypnotic drugs;
The patient who has taken psychiatric, hypnotic or antihistamine drugs during the last 4 weeks before baseline, however, the patient who use the prescription or nonprescription hypnotic drugs no more than twice a week can be recruited as soon as drug withdrawal;
The patient who is receiving ongoing psychological treatment;
The patient who has obstructive sleep apnea, restless leg syndrome, sleep rhythm disorders, parasomnias, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanrong Liang, Professor
Organizational Affiliation
Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xi Wu, A.P.
Organizational Affiliation
Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Chengdu university of Traditonal Chinese Medcine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China
12. IPD Sharing Statement
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Auricular Acupuncture for Primary Insomnia
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