Phase 2
N=15
Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
Sleep · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT02818569 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Hemodynamic Stability (Phase I) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexmedetomidine (Drug); Saline Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemodynamic Stability (Phase I) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Polysomnography Sleep Quality (Phase II). |
15; 15 | — |
| SECONDARY Performance on the Psychomotor Vigilance Task (Phase II) |
5.8; 6.5; 14.5; 12.3 | — |
| SECONDARY Performance on the Motor Sequence Task (Phase II) |
12; 13 | — |
| SECONDARY Subjective Sleep Quality (Phase II) |
33; 36.3 | — |
Summary
The broad objective of this investigation is to assess the safety and efficacy of oral therapy with dexmedetomidine for the induction and maintenance of restful sleep.
Eligibility Criteria
Inclusion Criteria
- Age between 18-50
- Native English speaking
- ASA physical status classification P1 and P2 (stable chronic condition)
- Normal body habitus.
Exclusion Criteria
- 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
- Waking up before 5: 00 AM or after 10:00 AM on a regular basis.
- 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 50 years of age.
- Known or suspected sleep disorder(s).
Data sourced from ClinicalTrials.gov (NCT02818569). 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.