NCT04255901

Efficacy of Head-point Acupuncture on Insomnia

Efficacy of Head-point Acupuncture on Insomnia: A Prospective Case Series Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conduct a single-center case series study. A total of 40 participants with insomnia will be enrolled. The aim of the study is to assess the therapeutic effect of head-point acupuncture for the treatment of insomnia.

Detailed description

The investigators will conduct a single-center case series study. A total of 40 participants with insomnia will be enrolled, and will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 acupuncture treatment for 4 weeks. The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6. The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).

Conditions

• Sleep Initiation and Maintenance Disorders

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2020-02-05
• Last updated: 2020-07-14