Clinical trial NCT06258226: A Randomized Controlled Trial of Auricular Acupressure in Treating Estazolam-dependent Insomnia
Official title: A Randomized Controlled Trial of Auricular Acupressure on Reduction of Estazolam in Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Estazolam-dependent Insomnia
Keywords: auricular acupressure
estazolam
insomnia
drug-dependent
estazolam-dependent insomnia
randomized controlled trial
Lead sponsor: Wenzhou Central Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Estazolam Dosing and Reduction Rates
timeFrame: 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
measure: Serum Gamma-aminobutyric acid and Cortisol Levels
timeFrame: 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:
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 4 weeks after treatment commencement, and the 1-month follow-up
measure: Benzodiazepine Withdrawal Symptom Questionnaire
timeFrame: Baseline, 4 weeks after treatment commencement, and the 1-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Wenzhou Central Hospital
name: Qiqi Wu
role: PRINCIPAL_INVESTIGATOR
References: