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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Drug: Dexmedetomidine and conventional oral drug; Drug: Conventional oral drug therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Zhao; Phone Number: 13911076631; Email: 718328043@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine group; Dexmedetomidine was administered intravenously once daily for three consecutive days, supplementing conventional oral drug therapy.	Drug: 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.
Other: Control group; Patients only received conventional oral drug therapy.	Drug: Conventional oral drug therapy; Patients only received conventional oral drug therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of NREM-N3 sleep within total sleep time, as recorded by polysomnogram the night before discharge,an average of 7 days.	After the end of anesthesia-induced sleep therapy, the percentage of NREM-N3 recorded by polysomnogram within total sleep time at the night before discharge,an average of 7 days.	At the night before discharge,an average of 7 days.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Inner Mongolia Autonomous Region Mental Health Center
• Investigators: Principal Investigator: Yuming Peng, MD,Ph.D, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Insomnia; Dexmedetomidine; Anesthesia-Induced Sleep
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: 20250701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No