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Clinical study on the effect of dexmedetomidine on chronic refractory insomnia

Clinical study on the effect of dexmedetomidine on chronic refractory insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051338
Enrollment
Unknown
Registered
2021-09-20
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic refractory insomnia

Interventions

Experimental group:Dexmedetomidine

Sponsors

The Second Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meeting the ICSD-3 diagnostic criteria for chronic insomnia; 2.Aged 18 to 65 years; 3.ISI score >=15; 4.Patients who have taken 2 or more drugs to improve sleep in the past, but are still not satisfied with the current treatment; 5.Patients who have good compliance and are willing to accept this therapy; 6.During the study period, subjects agreed not to start any new behavioral treatment program or other treatment program for insomnia.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Chronic insomnia that can be explained by the primary disease; 3.Medical history or history of mental illness that the investigator believes could affect the subject's safety or interfere with the study evaluation; 4.Abnormal electrocardiogram examination; 5.Planned or unplanned suicidal thoughts at the time of screening or within 6 months of screening; Or anyone who has committed suicide in the past 10 years; 6.diseases of clinical significance (e.g. cardiovascular disease; Respiratory diseases; Diseases of digestive system; Liver function damage; Kidney disease; Neurological diseases; Diseases of endocrine system; Infectious diseases; Mental illness; A history of malignancy) or chronic pain that the investigator felt might affect the subjects' safety or interfere with the study evaluation. Subjects whose sedatives are prohibited for safety reasons due to their occupation or activity are also excluded; 7.Patients who are allergic to dexmedetomidine or its excipients or are not suitable for treatment with dexmedetomidine as assessed by professional anesthesiologists; 8.Planned surgery during the study period; 9.Currently diagnosed sleep-related breathing disorders include obstructive apnea, periodic limb movement disorder, restless leg syndrome, circadian rhythm disorder, or narcolepsy; 10.During the follow-up period, the patient was lost to follow-up due to various reasons, and the patient withdrew due to other arbitrary reasons; 11.Patients with a history of alcoholism or excessive drinking of coffee or strong tea; 12.Participate in other clinical investigators.

Design outcomes

Primary

MeasureTime frame
Sleep efficiency;N3;

Secondary

MeasureTime frame
LPS;wake after sleep onset, WASO;sSOL;PSQI;Hamilton Anxiety Scale, HAMA;Hamilton depression scale, HAMD;Self-Rating Anxiety Scale, SAS;Self-Rating Depression Scale, SDS;

Countries

China

Contacts

Public ContactSun Xude

The Second Affiliated Hospital of Air Force Military Medical University

sunxude@fmmu.edu.cn+86 13891905550

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026