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A prospective cohort study of dexmedetomidine sublingual spray in insomnia disorders

A prospective cohort study of dexmedetomidine sublingual spray in insomnia disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121067
Enrollment
Unknown
Registered
2026-03-25
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Insomnia disorder

Interventions

Observation group:None

Sponsors

The First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age of 18-65 years old, male or female; BMI 18-30 kg/m². 2. DSM-5 insomnia disorder >=3 months, >=3 nights/week. 3. ISI >=15 (moderate and above). 4. PSG of adaptation night: AHI <10 /h, PLMI (with arousal) <15 /h. 5. Liver and kidney function, blood routine were normal, and there was no history of cardiovascular and cerebrovascular diseases. 6. Provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Other major sleep disorders: moderate to severe sleep apnea (AHI =10 /h), narcolepsy, REM behavior disorder, circadian rhythm sleep-wake disorder (delayed >2 h shift). 2. Major depression (HAMD-17 >17), bipolar disorder, psychotic disorder. 3. Significant cognitive impairment (MoCA =15) or drug abuse. 10. Any condition judged by the investigator to affect adherence or safety.

Design outcomes

Primary

MeasureTime frame
Sleep microstructure and quality;Dose-response relationship;

Countries

China

Contacts

Public ContactHuijie Tang

The First People's Hospital of Yunnan Province

dior.tang@163.com+86 15 982 527 9269

Outcome results

None listed

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