A Randomized Controlled Trial of Auricular Acupressure in Treating Estazolam-dependent Insomnia (ESAAEDI)

Wenzhou Central Hospital

Status: Not yet enrolling

Conditions: Estazolam-dependent Insomnia

Treatments: Procedure: Auricular acupressure; Procedure: Sham auricular acupressure; Drug: Conventional dosage reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT06258226

Y2023213

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 108 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

Conventional dosage reduction group

Active Comparator group

Description:

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.

Treatment:

Drug: Conventional dosage reduction

Auricular acupressure group

Experimental group

Description:

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.

Treatment:

Procedure: Auricular acupressure

Sham auricular acupressure group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham auricular acupressure