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

NCT07255027 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-28

No results posted yet for this study

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

Interventions

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.

DRUG

Conventional oral drug therapy

Patients only received conventional oral drug therapy.

Sponsors & Collaborators

  • Inner Mongolia Autonomous Region Mental Health Center

    collaborator UNKNOWN

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Yuming Peng, MD,Ph.D · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-07-01
Completion
2027-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255027 on ClinicalTrials.gov