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

NCT07255027 | Not Yet Recruiting

• 1 other identifier: 20250701
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Keywords

Anesthesia-Induced Sleep; Insomnia; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine and conventional oral drug

Control group

OTHER

Patients only received conventional oral drug therapy.

Drug: Conventional oral drug therapy

Interventions

Dexmedetomidine and conventional oral drug 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.

Dexmedetomidine group

Conventional oral drug therapy DRUG

Patients only received conventional oral drug therapy.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Inner Mongolia Autonomous Region Mental Health Center: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhao

CONTACT

13911076631; 718328043@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-09