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

NCT ID: NCT06258226

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-06-30

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%.

Conditions

Estazolam-dependent Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional dosage reduction group

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.

Group Type: ACTIVE_COMPARATOR

Conventional dosage reduction

Intervention Type: 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.

Auricular acupressure group

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.

Group Type: EXPERIMENTAL

Auricular acupressure

Intervention Type: 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.

Sham auricular acupressure group

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.

Group Type: SHAM_COMPARATOR

Sham auricular acupressure

Intervention Type: 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.

Interventions

Conventional dosage reduction

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.

Intervention Type: DRUG

Auricular acupressure

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Estazolam reduction

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wenzhou Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qiqi Wu

Resident physician of TCM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiqi Wu

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Central Hospital

Central Contacts

Qiqi Wu

Role: CONTACT

wuqiqi_0722@163.com

+8617826867387

References

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.

Reference Type: DERIVED

PMID: 39395964 (View on PubMed)

Other Identifiers

Y2023213

Identifier Type: -

Identifier Source: org_study_id