Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic

NCT02818569 | Completed Phase 1 Results DMC

• 1 other identifier: 2016P000269
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Insomnia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Performance on the Psychomotor Vigilance Task (Phase II)

  Active study night, visit 3 or 4

• Performance on the Motor Sequence Task (Phase II)

  Active study night, visit 3 or 4

• Subjective Sleep Quality (Phase II)

  Active study night, visit 3 or 4

Study Arms (2)

Oral Dexmedetomidine, Then Placebo

EXPERIMENTAL

This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator.

Drug: Dexmedetomidine; Other: Saline Placebo

Placebo, Then Oral Dexmedetomidine

EXPERIMENTAL

This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine .

Drug: Dexmedetomidine; Other: Saline Placebo

Interventions

Dexmedetomidine DRUG

Oral form

Also known as: Precedex

Oral Dexmedetomidine, Then Placebo; Placebo, Then Oral Dexmedetomidine

Saline Placebo OTHER

Saline Placebo

Also known as: Saline

Oral Dexmedetomidine, Then Placebo; Placebo, Then Oral Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-50
• Native English speaking
• ASA physical status classification P1 and P2 (stable chronic condition)
• Normal body habitus.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Oluwaseun Johnson-Akeju
• Organization: Massachusetts General Hospital

ojohnsonakeju@partners.org

617-724-7200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesia

Model Details: Patients will receive both the oral dexmedetomidine intervention and placebo comparator in a randomized order.

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 29, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-10

Locations

US (1)