A Randomized Controlled Trial of Auricular Acupressure in Treating Estazolam-dependent Insomnia
- Conditions
- Estazolam-dependent Insomnia
- Interventions
- Procedure: Sham auricular acupressureDrug: Conventional dosage reductionProcedure: Auricular acupressure
- Registration Number
- NCT06258226
- Lead Sponsor
- Wenzhou Central Hospital
- Brief Summary
Insomnia is a disorder characterized by difficulties in falling asleep, maintaining sleep or waking up too early, and impairment of daytime functioning. Drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period of time, and becoming psychologically and physiologically dependent on them. In many countries, auricular acupressure (AA) has attracted growing attention as a complementary or alternative treatment for insomnia; however, there is a lack of rigorous randomized, controlled studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia.
- Detailed Description
This study is a randomized, single-blinded, three-arm controlled trial. No less than 120 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 108
- Meet the diagnostic criteria for insomnia;
- Meet the diagnostic criteria for hypnotic drug-dependent insomnia;
- Regularly taking estazolam tablets for more than 2 months, and need to stop the medication;
- The dependent dosage of estazolam is 1mg, and withdrawal reaction occurs when the dosage is less than 1mg;
- PSQI score ≥ 7 (defined as "poor sleep quality", PSQI ≥ 7 is used as the reference threshold for judging sleep quality problems);
- Sign the informed consent.
- Patients with cognitive disorders caused by cerebrovascular diseases, psychiatric disorders, and so on;
- Patients with serious heart, liver, kidney and blood system diseases;
- Patients with psychiatric illness/drug abuse (including alcohol);
- Patients who cannot cooperate with treatment, observation and evaluation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham auricular acupressure group Sham auricular acupressure Based on the estazolam reduction method in the control group, the acupuncturist will place the same skin-colored adhesive tapes without vaccaria on the auricular points, but these tapes will not be pressed during treatment. Conventional dosage reduction group Conventional dosage reduction The drug reduction method of estazolam tablets (Shanghai Xinyi Pharmaceutical Co., Ltd., Shanghai, China, State Drugs Administration License No.: H31020644, 1 mg) will be given, with a starting dose of 1 mg, that is, the dosage of estazolam will be reduced by 25% (0.25mg) every week until the dosage will be stopped completely on the premise of no aggravation of insomnia symptoms. Auricular acupressure group Auricular acupressure Auricular acupressure therapy will be added based on the estazolam reduction method in the control group. The specific auricular points to be treated are Shenmen (TF4), Sympathetic (AH6), Endocrine (CO18), Heart (CO15), Liver (CO12) and Kidney (CO10). During the treatment, the acupuncturist will use a metal probe to identify the auricular points and ask the patients if they experience "deqi" sensations such as heat, numbness, distension, or pain. Once the auricular points have been confirmed, the ear will be disinfected using a 75% ethanol solution and dried using a sterile dry cotton ball. The acupuncturist will then hold the ear in place with their left hand while using their right hand to manipulate a tweezer and apply tape (0.5 x 0.5 cm) with vaccaria (Suzhou Konakang Medical Instrument Co., LTD., Suzhou, China) to the selected auricular point.
- Primary Outcome Measures
Name Time Method Estazolam Dosing and Reduction Rates Estazolam dosing will be assessed before treatment，1, 2, 3, and 4 weeks after treatment，1 month after follow-up visiting. The rate of dosage reduction will be observed 4weeks after treatment，1 month after follow-up visiting The amount of drug taken by patients will be assessed.The rate of dosage reduction will be observed. Estazolam reduction rate = (pre-treatment Estazolam dose - post-treatment Estazolam dose)/pre-treatment Estazolam dose x 100%.
Serum Gamma-aminobutyric acid and Cortisol Levels Venous blood samples will be drawn twice from each patient at 8:00-9:00 in the morning 1 day before treatment and 1 day after the end of treatment. The method of enzyme-linked immunosorbent assay (ELISA) will be used. 4 ml of venous blood will be extracted from the subjects, and will be added anticoagulant. After that, the samples will be centrifuged at 3000 r/min to separate upper serum and preserved in a refrigerator at -80℃, according to the kit instructions.
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index Baseline, 4 weeks after treatment commencement, and the 1-month follow-up The Pittsburgh Sleep Quality Index is a self-rated questionnaire used to assess sleep quality and disturbances over a 1-month period. It comprises 19 self-rated items and five other-rated items. The scores for the 19 self-rated items and five other-rated items are not included in the total score. Except for the first item, the remaining 18 items include the seven following subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficacy, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each subscale is rated from 0 to 3, and the accumulated scores of the seven subscales constitute the total score of the PSQI (0-21), where 7 is the threshold value of the sleep quality problem. A higher score indicates more severe sleep disorders.
Benzodiazepine Withdrawal Symptom Questionnaire Baseline, 4 weeks after treatment commencement, and the 1-month follow-up A self-report questionnaire is described which records the main symptoms experienced during withdrawal from benzodiazepines in pharmacologically dependent patients. The questionnaire consists of 20 items