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

NCT06258226 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-02-14

No results posted yet for this study

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

Interventions

DRUG

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.

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Wenzhou Central Hospital

    lead OTHER

Principal Investigators

  • Qiqi Wu · Wenzhou Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06258226 on ClinicalTrials.gov