Study on the Efficacy and Safety of Anesthesia-Induced Sleep Therapy for Refractory Insomnia

Официальное название

Study on the Efficacy and Safety of Anesthesia-Induced Sleep Therapy for Refractory Insomnia: A Randomized Controlled Trial

Обзор

The incidence of refractory insomnia is rising annually, with traditional therapies offering limited efficacy. Anesthesia-Induced Sleep (AIS), involving anesthetic infusion like dexmedetomidine, is emerging. Its ability to mimic natural sleep architecture is unclear. Studies confirm AIS can shorten latency and improve sleep efficiency, but neuromodulatory mechanisms and long-term efficacy remain unclear with scarce follow-up data. This study used dexmedetomidine-based AIS under polysomnography to validate its induction of normal sleep architecture, evaluate long-term efficacy and safety, and explore mechanisms, aiming to provide a novel non-pharmacological intervention.

Подробное описание

The incidence of refractory insomnia has been rising annually, severely impacting patients' quality of life. Traditional pharmacological and physical therapies offer limited efficacy and struggle to achieve long-term relief. Anesthesia-Induced Sleep (AIS), an emerging treatment, typically involves intravenous infusion of anesthetic agents like dexmedetomidine to rapidly induce sleep. However, whether it can mimic natural sleep architecture remains unclear. Recent domestic and international studies have preliminarily confirmed that AIS can shorten latency and improve sleep efficiency. However, issues such as unclear neuromodulatory mechanisms and fluctuating long-term efficacy persist, and large-scale long-term follow-up data remain scarce. This study implemented dexmedetomidine-based AIS under polysomnographic monitoring to validate its ability to induce normal sleep architecture (e.g., restoring slow-wave sleep proportion) while evaluating long-term efficacy and safety. By quantifying sleep parameters and neural electrical activity, we explored potential mechanisms of AIS in reshaping sleep homeostasis. This research aims to provide a novel non-pharmacological intervention strategy for refractory insomnia and advance clinical translation.

Вмешательства

• Препарат Dexmedetomidine and conventional oral drug
  Dexmedetomidine was administered intravenously once daily for three consecutive days, supplementing conventional oral drug therapy. The dexmedetomidine was administered via a loading dose of 1.5 μg/kg intravenously over 15 minutes, with a subsequent continuous infusion at a maintenance dose of 0.5-0.7 μg/kg/h.
• Препарат Conventional oral drug therapy
  Patients only received conventional oral drug therapy.

Первичные конечные точки

• The percentage of NREM-N3 sleep within total sleep time, as recorded by polysomnogram the night before discharge,an average of 7 days. [Срок оценки: At the night before discharge,an average of 7 days.]

Критерии участия

Критерии включения

• Adults aged 18-65 years meeting ICSD-3 diagnostic criteria for chronic insomnia.
• Persistent sleep disturbance (≥3 nights/week for ≥3 months).
• Significant daytime impairment (e.g., mood disturbance, cognitive decline).
• Treatment-refractory (failed prior pharmacotherapy/non-pharmacotherapy).
• No chronic obstructive pulmonary disease, moderate to severe sleep apnea syndrome, or atrioventricular block.
• Obtain written informed consent.

Критерии исключения

• Participants with severe concomitant diseases affecting other organ systems.
• Moderate to severe obstructive sleep apnea (e.g., AHI ≥30 events/hour) or uncontrolled central sleep apnea.
• Pregnant, lactating, or planning pregnancy.
• History of alcoholism or drug dependence.
• Suicidal ideation or a severe psychiatric history (e.g., schizophrenia, unstable bipolar disorder).
• Participants with a prior allergic reaction to the study drug.
• Participants who have recently participated in other clinical studies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07255027 · 20250701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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