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N/A N=10 Randomized Basic Science

Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Insomnia

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Sleep Quality — 33.2; 0; -35; 0 minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Dexmedetomidine (Drug); Zolpidem (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Sleep Quality
33.2; 0; -35; 0; 35.8; 26.8
SECONDARY
Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep
26; 12

Summary

The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.

Eligibility Criteria

Inclusion Criteria

  • Primary Inclusion Criteria for "Insomniac" subjects:

Subjects will be deemed "Insomniacs" if they suffer from any of the following:

  • Subject will be required to meet the criteria for insomnia, set by the International Classification of Sleep Disorders, which requires that a patient have difficulty initiating or maintaining sleep that is not accounted for by another sleep disorder, neurologic or psychiatric disorder or substance or medication.
  • Subject will be required to not be on any current pharmacological sleep disorder treatment.
  • Between the ages of 18 and 35 years.
  • Not taking any prescription medications that alter sleep, cognitive functions, or both.

Exclusion Criteria

Primary Exclusion Criteria for "Healthy" control subjects:

  • Abnormal sleep habits:
  • sleeping less than 5 hours each night;
  • going to sleep before 9: 00 PM or after 2:00 AM on a regular basis; or
  • Waking up before 5: 00 AM or after 10:00 AM on a regular basis. This will be objectively assessed by wrist actigraphy measured for a 1-week duration prior to the first study night.
  • A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.
  • A score greater than or equal to 10 on the Epworth Sleepiness Scale.
  • Takes medication that alters sleep, cognitive function, or both.
  • Has a history of a known neurological or psychiatric problem.
  • Younger than 18 or older than 35 years of age.
  • Known or suspected sleep disorder(s).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01485393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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