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Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia

NCT05615727 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-11-14

No results posted yet for this study

Summary

Insomnia is a significant public health burden, increasing work absenteeism and health care costs in a large proportion of the population. It causes altered cognition, emotional disturbances, and reduced quality of life. The purpose of this study is to determine whether the sleep promoting effect of dexmedetomidine is superior to the conventional sleep promoting drug, zolpidem.

The main outcome of this study is to measure the time taken to fall asleep. Investigators will also look at incidences of wakening after sleep onset, sleep quality and wake time during sleep.

Conditions

Interventions

DRUG

Dexmedetomidine

2 mcg/kg of undiluted dexmedetomidine \[= 0.02 ml/kg\] and oral placebo tablet

DRUG

Zolpidem

zolpidem 10 mg and intranasal saline 0.02 ml/kg

OTHER

Placebo

a placebo oral tablet and intranasal saline at 0.02 ml/kg

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Micheal Garnet Irwin, M.B. Ch.B · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-30
Completion
2024-09-30

Countries

  • China

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Entities

Diseases

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 NCT05615727 on ClinicalTrials.gov