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

Capital Medical University

Status: Not yet enrolling

Conditions: Insomnia

Treatments: Drug: Dexmedetomidine and conventional oral drug; Drug: Conventional oral drug therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07255027

20250701

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Dexmedetomidine group

Active Comparator group

Description:

Dexmedetomidine was administered intravenously once daily for three consecutive days, supplementing conventional oral drug therapy.

Treatment:

Drug: Dexmedetomidine and conventional oral drug

Control group

Other group

Description:

Patients only received conventional oral drug therapy.

Treatment:

Drug: Conventional oral drug therapy