Clinical trial NCT05830877: The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
Official title: The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Insomnia
Keywords: acupuncture
Primary Insomnia
RCT
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.


Eligibility criteria: Inclusion Criteria:

* Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
* Age range: 18-70 years old;
* PSQI score\>7 points; SAS score \> 50 or SDS score \> 53;
* No communication and cognitive impairment;
* No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
* Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;
* Sign an informed consent form prior to the start of the study.

Exclusion Criteria:

* Those who do not meet the inclusion criteria;
* Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
* Those with severe liver and renal insufficiency and bleeding tendencies;
* Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
* People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
* Pregnant or nursing;
* Those with other major diseases and poor control;
* Other persons who are unwilling to sign informed consent.

Primary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: Before treatment
measure: Pittsburgh sleep quality index
timeFrame: the 4th week of treatment
measure: Pittsburgh sleep quality index
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: Fatigue Scale-14
timeFrame: Before treatment
measure: Fatigue Scale-14
timeFrame: the 4th week of treatment
measure: Fatigue Scale-14
timeFrame: 4 weeks after treatment
measure: Epworth Sleepiness Scale
timeFrame: Before treatment
measure: Epworth Sleepiness Scale
timeFrame: he 4th week of treatment
measure: Epworth Sleepiness Scale
timeFrame: 4 weeks after treatment
measure: Self-Rating Anxiety Scale
timeFrame: Before treatment
measure: Self-Rating Anxiety Scale
timeFrame: 4th week of treatment
measure: Self-Rating Anxiety Scale
timeFrame: 4 weeks after treatment
measure: Self-rating depression scale
timeFrame: Before treatment
measure: Self-rating depression scale
timeFrame: the 4th week of treatment
measure: Self-rating depression scale
timeFrame: 4 weeks after treatment
measure: Polysomnography
timeFrame: the 4th week of treatment
measure: Heart rate variability
timeFrame: the 4th week of treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References: