Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Dexmedetomidine; Zolpidem

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Comorbid diagnosis of psychiatric disorders ( major depression, anxiety disorders, bipolar disorders and psychotic disorders)

2. Obstructive sleep apnoea as determined by an Apnea Hypoapnea Index of >15 or snoring.

3. Restless legs, or periodic limb movements during sleep as measured by the Periodic Limb Movements Index with arousal of > 15 per hour

4. Obesity (body mass index > 30)

5. Known or suspected cardiovascular, pulmonary, metabolic disease or diabetes as confirmed by the clinician interview during recruitment

6. Pregnancy

7. Anyone who has taken trans-meridian travel across more than one time-zone or worked night shifts in the preceding three months

8. Consuming prescribed or non-prescription sleep medication in the past month