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

NCT ID: NCT07255027

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-08-01

Brief Summary

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.

Detailed 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.

Conditions

Insomnia

Study Design

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

Study Groups

Dexmedetomidine group

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine and conventional oral drug

Intervention Type: 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.

Control group

Patients only received conventional oral drug therapy.

Group Type: OTHER

Conventional oral drug therapy

Intervention Type: DRUG

Patients only received conventional oral drug therapy.

Interventions

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.

Intervention Type: DRUG

Conventional oral drug therapy

Patients only received conventional oral drug therapy.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inner Mongolia Autonomous Region Mental Health Center

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuming Peng

Deputy chief of Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuming Peng, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Central Contacts

Yan Zhao

Role: CONTACT

718328043@qq.com

13911076631

Other Identifiers

20250701

Identifier Type: -

Identifier Source: org_study_id