Chronic Insomnia Disorder
Conditions
Interventions
experimental group:Acupuncture+reduction of zolpidem tartrate
control group:Comfort acupuncture+reduction of zolpidem tartrate
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria of Western medicine, traditional Chinese medicine, and syndrome classification criteria of the above CID; (2) 18 years old = age<65 years old, gender not limited; (3) ISI<8 points (during the period of taking zolpidem tartrate); (4) Take zolpidem tartrate (10mg) for at least 3 months and ensure a weekly frequency of at least 3 nights; (5) The patient has the intention to discontinue the use of zolpidem tartrate medication; (6) There has been at least one experience of self discontinuation of zolpidem tartrate in the past; (7) Agree to participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Long term night work or irregular sleep patterns; (2) Have a history of drug abuse or addiction; (3) Have taken sedative hypnotic drugs or antipsychotic drugs other than zolpidem tartrate within 2 weeks prior to the baseline visit, or have received other treatments related to insomnia (such as cognitive-behavioral therapy) within 3 months prior to the baseline visit; (4) Individuals with obstructive sleep apnea, abnormal sleep, and other sleep related disorders; (5) Individuals with mental disorders such as schizophrenia, bipolar disorder, depression, anxiety, etc; (6) Merge serious primary diseases such as heart, lung, kidney, or hematopoietic system; (7) Individuals with intellectual disabilities who are unable to understand various scale items and cannot cooperate in completing the assessment; (8) Pregnant or lactating patients or those planning to conceive within the past 2 months; (9) He had received acupuncture and moxibustion treatment within one year before joining the group; (10) The acupuncture site may have ulcers, abscesses, skin infections, etc; (11) Participate in other clinical medical trial studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The discontinuation rate of zolpidem tartrate at week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| The reduction rate of zolpidem tartrate;The discontinuation rate of zolpidem tartrate at weeks 10 and 12;Frequency of zolpidem tartrate use (nights/week);Average daily dose of zolpidem tartrate (mg/day);Total weekly dose of zolpidem tartrate (mg/week);Change in the total score of ISI ;Change in the GAD-7 score; Change in the PHQ-9 score;Change in the SF-12 score;Sleep diary-related indicators;Change in the DBAS-16 score;Change in the ESS score; Emergency medication usage; | — |
Countries
China
Contacts
Public ContactPing Yin
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed