Clinical Trial

Intranasal Dexmedetomidine-esketamine on Sleep and Cognition in Older Adults With Mild-to-moderate Cognitive Impairment

Not Yet Recruiting Phase 4
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Summary
Patients with cognitive decline are frequently comorbid with sleep disorders which may in turn aggravate cognitive decline. Sedative dose dexmedetomidine improved sleep quality but incresed bradycardia and hypotension; low dose dexmedetomidine produce less side effects, but the sleep promoting effects are relatively weak. Low dose esketamine also has sleep-promoting effects but may produce neuropsychiatric side effects. Both dexmedetomidine and esketamine are approved for intranasal administration. We suppose that intranasal administration of dexmedetomidine-esketamine combination may improve sleep quality and therefore cognitive function in older ptients with Alzheimer's disease cognitive impairment and sleep disorders.
Protocol Amendment History 2 changes
critical Phase changed: not applicable -> Phase 4 2026-06-02
critical Primary endpoint(s) modified 2026-06-02
Trial Details
NCT Number NCT07610343
Lead Sponsor Peking University First Hospital
Conditions Older Adults, Cognitive Impairment, Sleep Disorders, Dexmedetomidine, Esketamine
Enrollment 60 participants
Start Date 2026-06
Primary Completion 2027-11 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-01