N/A
N=10
Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01485393 ↗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
| Outcome | Result | p-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).
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.