Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic

Insomnia Clinical Trial

Official title:

Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818569
• Other study ID #: 2016P000269
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Sleep is a basic human function that occupies approximately one-third of our lives. Much of what is known about the benefits of sleep in humans has been obtained from studies of patients with insomnia, the most common sleep disorder with a reported prevalence of 10 to 15%. Unfortunately, insomnia is an independent risk factor for acute myocardial infarction, coronary heart disease, heart failure, hypertension, diabetes, and death. More so, sleep disturbances lead to neurocognitive deficits such as delirium and psychosis. However, the principal medications (i.e. benzodiazepines, zolpidem) currently used to treat insomnia are associated with side effects such as daytime sedation, delirium, anterograde memory disturbance, and complex sleep-related behaviors. We recently found that a nighttime intravenous bolus administration of dexmedetomidine was associated with normal sleep architecture comprising of rapid eye movement (REM) and non-REM (N1, N2, N3) sleep, with improved next-day psychomotor vigilance performance compared to zolpidem. Presently, dexmedetomidine is only available in an intravenous formulation. The goal of this project is to develop dexmedetomidine, an alpha-2 receptor agonist, into an oral sleep therapeutic with a neurocognitive sparing profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia
• Sleep
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Dexmedetomidine
Oral form

Other:
• Saline Placebo
Saline Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic Stability (Phase I)	Number of participants with (1) systolic blood pressure (SBP) < 60 mmHg, diastolic blood pressure (DBP) < 40 mmHg or decrease of SBP by = 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP > 180 mmHg, DBP > 100 mmHg, or increase of SBP by = 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) < 40 bpm or decrease by = 50 % from the baseline sustained over two consecutive minutes.	Active study night, visit 3 or 4
Primary	Polysomnography Sleep Quality (Phase II).	Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep.	Active study night, visit 3 or 4
Secondary	Performance on the Psychomotor Vigilance Task (Phase II)	The number of responses that were longer than 400 milliseconds (lapse 400).	Active study night, visit 3 or 4
Secondary	Performance on the Motor Sequence Task (Phase II)	Number of participants with improved MST score after sleeping.	Active study night, visit 3 or 4
Secondary	Subjective Sleep Quality (Phase II)	Self-reported sleep latency.	Active study night, visit 3 or 4