NCT06212934|UnknownDMC
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Sponsor study identifier
interventional
96
1 country
1
Study Start
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this clinical trial is to learn about the curative effect of "Chou's Tiaoshen" acupoints in short-term insomnia and the explore the possible mechanism of the action. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2023
Actual (reported)January 19, 2024
Actual (reported)March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. Eighteen individual items generate seven "component" scores: subjective sleep quality (SQ), sleep-onset latency (SOL), total sleep time (TST), habitual sleep efficiency (SE), sleep disturbances ( Dyssomnia), use of sleeping medication, and daytime dysfunction (DD).The cumulative component score is the PSQI total score ranging from 0 to 21, higher scores indicates worse sleep quality.
PSQI will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
Polysomnography
PSG will be recorded in 10 randomly selected patients in each group before treatment and 14 days after treatment.
Heart Rate Variability (HRV)
HRV will be recorded 3 times, before treatment, at the 14th day and 28th day after treatment.
Concentration of serum cortisol
Serum cortisol will be recorded 2 times, before treatment, and at the 14th day , 28th day after treatment, and the measurement time was fixed at 8 am each time.
Fatigue Scale
FS will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
Ford Insomnia Response to Stress Test Chinese version，FIRST
FIRST will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
Acupuncturing"Chou's Tiaoshen" acupoints,"Chou's Tiaoshen" acupoints is derived from the experience of Zhou Dean, anational famous traditional Chinese medicine doctor in our department.
Estazolam is a drug commonly used in the treatment of insomnia
"Chou's Tiaoshen" acupoints includes Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1), Sanyinjiao (SP-6), Shenmen (HT-7) . Using stainless steel needles (0.32×40)mm, HuaTuo, China). Then some other points like, Danzhong(CV-17), Daling(PC-7), Taixi (KI-3), Qihai (CV-6), Taichong (LR3), and Qiuxu(GB-40) are chosen. Operation: Patients in supine position. Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1) are punctured at a depth of 20-25mm obliquely. Sanyinjiao (SP-6) and Shenmen (HT-7) are inserted 15mm perpendicularly. Until feeling tactile sensation then manually manipulated by rotation methods to produce a characteristic sensation known as "De Qi"; Technique: Mild reinforcing and attenuating, retaining the needle for 30minutes. The treatment will be givenonce a day and 5 times a week in weekdays, the course will last two weeks.
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100000, China
Huanqin Li, Doctor
Beijing Hospital of Traditional Chinese Medicine
First Submitted
December 22, 2023
First Posted
January 19, 2024
Study Start
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus
Participants will take estazolam 1mg 30min prior to bedtime everyday. The course of treatment is two weeks.
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Contact the study team to confirm eligibility.
March 1, 2025
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 19, 2024
Record last verified: 2024-01
We plan to publish a protocol of this trial in about 6-8 months after the registration, and one paper of the trial including results in a high-impact peer reviewed journal in one year after the trial. About two years after the end of this trial and our open publication of the result, the primary data and type of analysis will be available for 5-10 years until data updated by a more specific study with larger number of participants. Anyone who are interested in the trial can ask us to share the primary data by send a requirement through email. We provide the collected primary data without no real information of participants, all the data sequence will be numbered instead of real names.
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Source: ClinicalTrials.gov.
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