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

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary endpoint(s) modifiedv2 Show 7 more changesShow less
    • Phase changed: not applicable → Phase 4
    • Start date: Jun 1, 2026 to Jun 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 314 words
    • Site details revised
    • Study title revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07610343
Lead Sponsor Peking University First Hospital
Conditions
(from sponsor)		 Older Adults, Cognitive Impairment, Sleep Disorders, Dexmedetomidine, Esketamine
Related terms Cognitive Dysfunction, Sleep Wake Disorders
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov