Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia

NCT05615727 | Unknown Phase 3

• 1 other identifier: UW 21-386
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia

Keywords

Insomnia; Dexmedetomidine; Zolpidem

Outcome Measures

Primary Outcomes (1)

• Sleep onset latency

  Sleep onset latency is a measure of how long it takes for the participant to fall asleep once the participant gets into bed. This will be measured in minutes and reported as minutes for each of the treatments

  720 minutes

Secondary Outcomes (1)

• Incidence of wakening after sleep onset; Sleep quality; Wake time during sleep

  720 minutes

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Zolpidem

ACTIVE COMPARATOR

Drug: Zolpidem

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine

Zolpidem DRUG

zolpidem 10 mg and intranasal saline 0.02 ml/kg

Zolpidem

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged between 18 to 25 years, with DSM-5 insomnia disorder. Insomnia will be diagnosed and confirmed by a clinical interview and will have an Insomnia Severity Index score of ≥ 15.

You may not qualify if:

• Comorbid diagnosis of psychiatric disorders ( major depression, anxiety disorders, bipolar disorders and psychotic disorders)
• Obstructive sleep apnoea as determined by an Apnea Hypoapnea Index of \>15 or snoring.
• Restless legs, or periodic limb movements during sleep as measured by the Periodic Limb Movements Index with arousal of \> 15 per hour
• Obesity (body mass index \> 30)
• Known or suspected cardiovascular, pulmonary, metabolic disease or diabetes as confirmed by the clinician interview during recruitment
• Pregnancy
• Anyone who has taken trans-meridian travel across more than one time-zone or worked night shifts in the preceding three months
• Consuming prescribed or non-prescription sleep medication in the past month

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

HKU Li Ka Shing Faculty of Medicine

Hong Kong, Guangdong, 999077, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines

Study Officials

• Micheal Garnet Irwin, M.B. Ch.B

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Micheal Garnet Irwin, M.B. Ch.B

CONTACT

22553303/ 97018342; mgirwin@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: placebo-controlled crossover trial
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Each participant will take part in three sleep investigations. Each sleep investigation will take place after the participant has completed one night of sleep familiarization in the laboratory. The 3 sleep investigations will be conducted after administration of the following in a randomised manner: 1. Placebo 2. Intranasal dexmedetomidine 3. Zolpidem

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 14, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CN (1)