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

NCT06258226 | Not Yet Recruiting DMC

• 1 other identifier: Y2023213
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Estazolam-dependent Insomnia

Keywords

auricular acupressure; estazolam; insomnia; drug-dependent; estazolam-dependent insomnia; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Estazolam Dosing and Reduction Rates

  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%.

  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

• Serum Gamma-aminobutyric acid and Cortisol Levels

  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.

  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.

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index

  Baseline, 4 weeks after treatment commencement, and the 1-month follow-up

• Benzodiazepine Withdrawal Symptom Questionnaire

  Baseline, 4 weeks after treatment commencement, and the 1-month follow-up

Study Arms (3)

Conventional dosage reduction group

ACTIVE COMPARATOR

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.

Drug: Conventional dosage reduction

Auricular acupressure group

EXPERIMENTAL

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.

Procedure: Auricular acupressure

Sham auricular acupressure group

SHAM COMPARATOR

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.

Procedure: Sham auricular acupressure

Interventions

Conventional dosage reduction DRUG

The doctor will guide patients to adjust medication dosage once a week in the outpatient clinic. When patients experience withdrawal reactions such as worsening insomnia or anxiety symptoms due to drug reduction, they will be returned to the oral dose before the current reduction, and the dosage will be reduced again after evaluation in the next reduction cycle. The treatment for 4 weeks is one course and 1 course of treatment is required totally.

Also known as: Estazolam reduction

Conventional dosage reduction group

Auricular acupressure PROCEDURE

Auricular acupressure is a non-pharmacological therapy that involves applying acupressure on the surface of points in different parts of the ear. One side of the auricular acupoints will be treated first and the tapes will be kept in place for 3 days. On the fourth day, the tapes on the ear will be removed and new tapes will be applied to the opposite side of the ear. The purpose of replacing tapes is to reduce the adverse events (AEs) that may be caused by long-term stimulation unilaterally. In addition, the participants will be informed to press the tapes by themselves for 3 to 5 minutes vertically and appropriately to achieve the sensation, with a duration of 4 to 5 times a day. The treatment will last for 4 weeks, and the follow-up will be done after 1 month.

Auricular acupressure group

Sham auricular acupressure PROCEDURE

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.

Sham auricular acupressure group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenzhou Central Hospital: lead

Related Publications (1)

• Wu Q, Wang J, Fan L, Qian L, Han D, Hu H, Gao H. Efficacy and safety of auricular acupressure on reduction of estazolam in patients with insomnia: a study protocol for a three-arm, blinded randomized controlled trial. BMC Complement Med Ther. 2024 Oct 12;24(1):367. doi: 10.1186/s12906-024-04651-7.

  PMID: 39395964 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Qiqi Wu

  Wenzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiqi Wu

CONTACT

+8617826867387; wuqiqi_0722@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician of TCM

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 14, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share