Phase 2
Completed N=15
Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
Sleep · Insomnia
Source: ClinicalTrials.gov NCT02818569 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Hemodynamic Stability (Phase I) — 0; 0; 0; 0 Participants
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.
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 | — |
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. Informational only — not medical advice.