Clinical trial NCT04255901: Efficacy of Head-point Acupuncture on Insomnia
Official title: Efficacy of Head-point Acupuncture on Insomnia: A Prospective Case Series Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: acupuncture
primary insomnia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. aged 20\~80 years,
2. persistent difficulty in either falling asleep, remaining asleep through the night, or waking up too early at least three nights a week for more than a month, and not suffered from any secondary diseases.

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. aged 20\~80 years,
2. met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
3. experienced insomnia at least three times a week for more than a month
4. voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.

Exclusion Criteria:

1. a pregnant or lactating woman
2. the patient's insomnia is caused by mental disorders other than mild anxiety,
3. the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
4. the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
5. the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
6. the patient with cardiac pacemaker
7. the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
8. the patient has a history of sleep apnea

Primary outcomes:
measure: Changes of The Epworth sleepiness scale (ESS)
timeFrame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
measure: Changes of The HADS(The Hospital Anxiety and Depression Scale)
timeFrame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
measure: Changes of The PSQI(Pittsburgh Sleep Quality Index)
timeFrame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Secondary outcomes:
measure: HRV(Heart rate viability)
timeFrame: 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, an average of 1 year.
measure: actigraphy (3-day)
timeFrame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
measure: sleep diary
timeFrame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Other outcomes:
Locations:
Study officials:
References: