Auricular Acupuncture for Primary Insomnia

Primary Insomnia Clinical Trial

— AAPI  

Official title:

Auricular Acupuncture for Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087488
• Other study ID #: 2011SZ0302-3
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• auricular acupuncture(AA)
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.
• placebo AA
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.

Drug:
• Eszopiclone
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.

Locations

Country	Name	City	State
China	Chengdu university of Traditonal Chinese Medcine	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline in SOL at 4 weeks
Primary	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.	Change from baseline in WASO at 4 weeks
Secondary	Pittsburgh Sleep Quality Index(PSQI)		Change from baseline in PSQI at 4 weeks
Secondary	Insomnia Severity Index (ISI)		Change from baseline in ISI at 4 weeks
Secondary	Beck Depression Inventory (BDI)		Change from baseline in BDI at 4 weeks
Secondary	State-Trait Anxiety Inventory (STAI)		Change from baseline in STAI at 4 weeks
Secondary	Self-rating Anxiety Scale (SAS)		Change from baseline in SAS at 4 weeks
Secondary	The Epworth Sleeping Scale (ESS)		Change from baseline in ESS at 4 weeks
Secondary	Flinders Fatigue Scale (FFS)		Change from baseline in FFS at 4 weeks
Secondary	The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)		Change from baseline in SF-36 at 4 weeks
Secondary	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.	Change from baseline in TST at 4 weeks
Secondary	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%.	Change from baseline in SE at 4 weeks
Secondary	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.	Change from baseline in nWAK at 4 weeks