A Randomized Controlled Trial On The Treatment Of College Students'Non-organic Insomnia With Tiao Xu Therapy

Objective: Observe the clinical efficacy and evaluate the safety of Tiao Xu apparatus in the treatment of non-organic insomnia in college students.Method: Sixty volunteers recruited from Tianjin Medical University and Nankai University who conformed to the ICD-10 non-organic insomnia diagnostic were randomly divided into study group(n=30)and control group(n=30).The study group was treated with Tiao Xu apparatus for 1 months,once a day for 30 minutes.The control group was treated with Tiao Xu apparatus fake treatment for the same time and frequency.The sleep data of subjects were measured by Zeo sleep manager headband before intervention,including sleep latency,deep sleep time,shallow sleep time,REM time,the number and time of awakening,and total sleep time.The sleep status of subjects was evaluated by Pittsburgh sleep quality index(PSQI).The degree of insomnia and daytime sleep were evaluated by the Insomnia Severity Index(ISI)and Epworth sleep scale(ESS),and the anxiety and depression levels were assessed by Self-rating Anxiety Scale(SAS)and Self-rating Depression Scale(SDS).The TESS scale was used to assess whether the subjects had adverse reactions during the course of treatment.The Stroop color words was tested by computer software to record the correct rate and reaction time.At the end of the treatment,the scales were evaluated again and the Zeo sleep manager headband measurement and the Stroop color word test were also performed.Result:Comparison between before and after treatment of study group: there were statistical differences(P<0.05)in the total score of Pittsburgh Sleep Index scale,component 1 sleep quality,component 2 sleep time,component 3 sleep time,component 5 sleep disorder and component 7 daytime dysfunction.Zeo sleep manager headband monitoring showed that there were statistical differences(P<0.05)before and after the treatment among the 6 indices which are sleep latency,arousal ratio,shallow sleep(min),total sleep time,sleep efficiency and sleep maintenance rate.There were statistical differences in the total scores of Insomnia Severity Index(ISI),Epworth Sleepiness Scale(ESS),Self-rating Anxiety Scale(SAS),and Self-rating Depression Scale(SDS)before and after treatment(P<0.05).There were statistical differences(P<0.05)in the total reaction time,reaction time of color word consistent and reaction time of color word conflict in the Stroop color word test.The results of TESS scale showed that the number of people who had new symptoms was 0 during treatment.The differences of before and after treatment between study group and control group were statistically significant(P<0.05),indicating that the changes were not due to the placebo effect.Conclusion: Tiao Xu apparatus can heal the college students' non-organic insomnia,reduce anxiety and depression level,reduce drowsiness in day time,and improve the attention and executive ability of the patients.Moreover,it has a great speed of action and no adverse side effects.