The Effect of Standard Cognitive-behavioral Therapy+Transcranial Alternating Current on Refractory Insomnia Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

CBTI + tACS: CBTI + tACS group method: CBTI for about 50 minutes each time, for a total of 6 weeks: ① first interview: enrolment assessment; ② second interview: treatment initiation; ③ third interview: sleep titration and sleep hygiene; ④ fourth interview: sleep titration; ⑤ fifth-seventh interview: sleep titration; ⑥ eighth interview: sleep titration (end of standardised CBTI treatment. tACS true stimulation) : Transcranial alternating current therapy (tACS) was operated during the same period of CBTI, with 3 electrodes, placed in the prefrontal lobe and bilateral mastoid; the stimulation intensity was 77.5 Hz, 15 mA, 40 min each time, once a day, 5 days a week, for 6 weeks.

CBTI + Sham tACS: CBTI+sham tACS group method: CBTI treatment method was the same as before. tACS pseudo-stimulation: the electrode placement position, stimulation frequency, and time settings were the same as the real stimulation, and the stimulation process only had the output of gradual rising and falling current at the beginning and the last 10s, respectively, so as to make the subjects produce the same subjective feelings as the real stimulation.

Study summary

The main purpose of this study is to investigate the efficacy of CBTI + transcranial alternating current (TAC) technology in the treatment of refractory insomnia and the mechanism of 'cognitive-behavioural-brain network' interactions.

Eligibility

Primary outcome measure(s)

• Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups — Baseline to week 6

Trial sites (1)

More Xuanwu Hospital, Beijing trials in China

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